Search results for: oral dosage form
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 7437

Search results for: oral dosage form

7437 Development of Self Emulsifying Drug Delivery Systems (SEDDS) of Anticancer Agents Used in AYUSH System of Medicine for Improved Oral Bioavailability Followed by Their Pharmacological Evaluation Using Biotechnological Techniques

Authors: Meenu Mehta, Munish Garg

Abstract:

The use of oral anticancer drugs from AYUSH system of medicine is widely increased among the society due to their low cost, enhanced efficacy, increased patient preference, lack of inconveniences related to infusion and they provide an opportunity to develop chronic treatment regimens. However, oral delivery of these drugs usually laid down by the limited bioavailability of the drug, which is associated with a wide variation. As most of the cytotoxic agents have a narrow therapeutic window and are dosed at or near the maximum tolerated dose, a wide variability in the bioavailability can negatively affect treatment result. It is estimated that 40% of active substances are poorly soluble in water. The improvement of bio-availability of drugs with such properties presents one of the greatest challenges in drug formulations. There are several techniques reported in literature. Among all these Self Emulsifying Drug Delivery System (SEDDS) has gained more attention due to enhanced oral bio-availability enabling a reduction in dose. Thus, SEDDS anticancer drugs will have the increased bioavailability and efficacy. These dosage form will provide societal benefit in a cost-effective manner as compared to other oral dosage forms. Present study reflects on the formulation strategies as SEDDS for oral anticancer agents of AYUSH system for enhanced bioavailability with proven efficacy by cancer cell lines.

Keywords: anticancer agents, AYUSH system, bioavailability, SEDDS

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7436 Solid Dosages Form Tablet: A Summary on the Article by Shashank Tiwari

Authors: Shashank Tiwari

Abstract:

The most common method of drug delivery is the oral solid dosage form, of which tablets and capsules are predominant. The tablet is more widely accepted and used compared to capsules for a number of reasons, such as cost/price, tamper resistance, ease of handling and packaging, ease of identification, and manufacturing efficiency. Over the past several years, the issue of tamper resistance has resulted in the conversion of most over-the-counter (OTC) drugs from capsules to predominantly all tablets.

Keywords: capsule, drug delivery, dosages, solid, tablet

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7435 Beliefs about the Use of Extemporaneous Compounding for Paediatric Outpatients among Physicians in Yogyakarta, Indonesia

Authors: Chairun Wiedyaningsih, Sri Suryawati, Yati Soenarto, Muhammad Hakimi

Abstract:

Background: Many drugs used in paediatrics are not commercially available in suitable dosage forms. Therefore, the drugs often prescribed in extemporaneous compounding dosage form. Compounding can pose health risks include poor quality and unsafe products. Studies of compounding dosage form have primarily focused on prescription profiles, reasons of prescribing never be explored. Objectives: The study was conducted to identify factors influencing physicians’ decision to prescribe extemporaneous compounding dosage form for paediatric outpatients. Setting: Daerah Istimewa Yogyakarta (DIY) province, Indonesia. Method: Qualitative semi-structured interviews were conducted with 15 general physicians and 7 paediatricians to identify the reason of prescribing extemporaneous compounding dosage form. The interviews were transcribed and analysed using thematic analysis. Results: Factors underlying prescribing of compounding could be categorized to therapy, healthcare system, patient and past experience. The primary reasons of therapy factors were limited availability of drug compositions, dosages or formulas specific for children. Beliefs in efficacy of the compounding forms were higher when the drugs used primarily to overcome complex cases. Physicians did not concern about compounding form containing several active substances because manufactured syrups may also contain several active substances. Although medicines were available in manufactured syrups, limited institutional budget was healthcare system factor of compounding prescribing. The prescribing factors related to patients include easy to use, efficient and lower price. The prescribing factors related to past experience were physicians’ beliefs to the progress of patient's health status. Conclusions: Compounding was prescribed based on therapy-related factors, healthcare system factors, patient factors and past experience.

Keywords: compounding dosage form, interview, physician, prescription

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7434 Analytical Method Development and Validation of Stability Indicating Rp - Hplc Method for Detrmination of Atorvastatin and Methylcobalamine

Authors: Alkaben Patel

Abstract:

The proposed RP-HPLC method is easy, rapid, economical, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of Astorvastatin and Methylcobalamine in their combined dosage form has been developed.The separation was achieved by LC-20 AT C18(250mm*4.6mm*2.6mm)Colum and water (pH 3.5): methanol 70:30 as mobile phase, at a flow rate of 1ml/min. wavelength of this dosage form is 215nm.The drug is related to stress condition of hydrolysis, oxidation, photolysis and thermal degradation.

Keywords: RP- HPLC, atorvastatin, methylcobalamine, method, development, validation

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7433 Development of Extemporaneous Pediatric Syrup of Prednisone

Authors: Amel Chenafa, Sihem Boulenouar, Linda Aoued, Imane Sediri, Ismahan Djebbar, Mohamed Adil Selka

Abstract:

Introduction: The specialties intended for adults are often inadequate marketed for pediatric use, such as for a galenic form or in the dosage. For an industrial, development of a pediatric drug is confronted to various problems. So, the hospital pharmacies have to respond to adaptation needs of pharmaceutical forms for pediatric use. The objective of our work is to develop an oral form of prednisone for pediatric use since no adapted form to children is commercialized. Materials and Methods: Therefore an extemporaneous syrup of prednisone was prepared at the concentration of 0,5mg/ml from 5mg tablets and stored in amber glass bottles. Organoleptic and microbiological stability was studied in two temperatures: 5°C and 25°C, and evaluated at D0, D15, and D30. Results: No organoleptic changes have been detected on the syrup conserved at 25 and 5°C. The results show that there is no presence of bacteria, yeasts, and molds in the syrups stored at both temperatures during the analysis period. Conclusion: Sheltered from light, the developed syrup of prednisone remained stable at room temperature and/or refrigerator for 30 days.

Keywords: extemporaneous syrup, pediatric drug, prednisone, stability

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7432 Characterization of Calcined Clay Blended Self Compacting Concrete-Correlation between Super-Plasticizer Dosage and Self Compacting Concrete Properties

Authors: Kumator Josiphiah Taku

Abstract:

Sustainability in construction is essential to the economic construction and can be achieved by the use of locally available construction materials. This research work, thus, uses locally available materials –calcined clay and Sandcrete SPR-300 superplasticizer in the production of Self Compacting Concrete (SCC) by investigating the correlation between the superplasticizer dosage and the fresh and hardened states properties of a grade 50 SCC made by incorporating a Calcined Clay (CC) – Portland Limestone Cement (PLC) blend as the cementitious matter at 20% replacement of PLC with CC and using CC as filler. The superplasticizer dosage was varied from 0.4 to 3.0% by weight of cementitious material and the slump, v-funnel, L-box and strength parameters investigated. The result shows a positive correlation between the increased dosage of the superplasticizer and the fresh and hardened states properties of the SCC up to 2% dosage. The J¬Spread¬, t¬500J¬, Slump flow, L-box H¬2¬/H¬1 ¬ratio and strength, all increases with SP dosage while the V-funnel flow decreased with SP dosage. Overall, SP ratio of 0.5 to 2.0 can be used in improving the properties of SCC produced using calcined clay both as filler and cementitious material.

Keywords: calcined clay, compressive strength, fresh-state properties of SCC, self compacting concrete, superplasticizer dosage

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7431 Oral Examination: An Important Adjunct to the Diagnosis of Dermatological Disorders

Authors: Sanjay Saraf

Abstract:

The oral cavity can be the site for early manifestations of mucocutaneous disorders (MD) or the only site for occurrence of these disorders. It can also exhibit oral lesions with simultaneous associated skin lesions. The MD involving the oral mucosa commonly presents with signs such as ulcers, vesicles and bullae. The unique environment of the oral cavity may modify these signs of the disease, thereby making the clinical diagnosis an arduous task. In addition to the unique environment of oral cavity, the overlapping of the signs of various mucocutaneous disorders, also makes the clinical diagnosis more intricate. The aim of this review is to present the oral signs of dermatological disorders having common oral involvement and emphasize their importance in early detection of the systemic disorders. The aim is also to highlight the necessity of oral examination by a dermatologist while examining the skin lesions. Prior to the oral examination, it must be imperative for the dermatologists and the dental clinicians to have the knowledge of oral anatomy. It is also important to know the impact of various diseases on oral mucosa, and the characteristic features of various oral mucocutaneous lesions. An initial clinical oral examination is may help in the early diagnosis of the MD. Failure to identify the oral manifestations may reduce the likelihood of early treatment and lead to more serious problems. This paper reviews the oral manifestations of immune mediated dermatological disorders with common oral manifestations.

Keywords: dermatological investigations, genodermatosis, histological features, oral examination

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7430 RP-HPLC Method Development and Its Validation for Simultaneous Estimation of Metoprolol Succinate and Olmesartan Medoxomil Combination in Bulk and Tablet Dosage Form

Authors: S. Jain, R. Savalia, V. Saini

Abstract:

A simple, accurate, precise, sensitive and specific RP-HPLC method was developed and validated for simultaneous estimation of Metoprolol Succinate and Olmesartan Medoxomil in bulk and tablet dosage form. The RP-HPLC method has shown adequate separation for Metoprolol Succinate and Olmesartan Medoxomil from its degradation products. The separation was achieved on a Phenomenex luna ODS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of acetonitrile: 50mM phosphate buffer pH 4.0 adjusted with glacial acetic acid in the ratio of 55:45 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 225nm. The retention time for Metoprolol Succinate and Olmesartan Medoxomil was 2.451±0.1min and 6.167±0.1min, respectively. The linearity of the proposed method was investigated in the range of 5-50μg/ml and 2-20μg/ml for Metoprolol Succinate and Olmesartan Medoxomil, respectively. Correlation coefficient was 0.999 and 0.9996 for Metoprolol Succinate and Olmesartan Medoxomil, respectively. The limit of detection was 0.2847μg/ml and 0.1251μg/ml for Metoprolol Succinate and Olmesartan Medoxomil, respectively and the limit of quantification was 0.8630μg/ml and 0.3793μg/ml for Metoprolol and Olmesartan, respectively. Proposed methods were validated as per ICH guidelines for linearity, accuracy, precision, specificity and robustness for estimation of Metoprolol Succinate and Olmesartan Medoxomil in commercially available tablet dosage form and results were found to be satisfactory. Thus the developed and validated stability indicating method can be used successfully for marketed formulations.

Keywords: metoprolol succinate, olmesartan medoxomil, RP-HPLC method, validation, ICH

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7429 Formulation, Preparation, and Evaluation of Coated Desloratadine Oral Disintegrating Tablets

Authors: Mohamed A. Etman, Mona G. Abd-Elnasser, Mohamed A. Shams-Eldin, Aly H. Nada

Abstract:

Orally disintegrating tablets (ODTs) are gaining importance as new drug delivery systems and emerged as one of the popular and widely accepted dosage forms, especially for the pediatric and geriatric patients. Their advantages such as administration without water, anywhere, anytime lead to their suitability to geriatric and pediatric patients. They are also suitable for the mentally ill, the bed-ridden and patients who do not have easy access to water. The benefits, in terms of patient compliance, rapid onset of action, increased bioavailability, and good stability make these tablets popular as a dosage form of choice in the current market. These dosage forms dissolve or disintegrate in the oral cavity within a matter of seconds without the need of water or chewing. Desloratadine is a tricyclic antihistaminic, which has a selective and peripheral H1-antagonist action. It is an antagonist at histamine H1 receptors, and an antagonist at all subtypes of the muscarinic acetylcholine receptor. Desloratadine is the major metabolite of loratadine. Twelve different placebos ODT were prepared (F1-F12) using different functional excipients. They were evaluated for their compressibility, hardness and disintegration time. All formulations were non sticky except four formulations; namely (F8, F9, F10, F11). All formulations were compressible with the exception of (F2). Variable disintegration times were found ranging between 20 and 120 seconds. It was found that (F12) showed the least disintegration time (20 secs) without showing any sticking which could be due to the use of high percentage of superdisintegrants. Desloratadine showed bitter taste when formulated as ODT without any treatment. Therefore, different techniques were tried in order to mask its bitter taste. Using Eudragit EPO resulted in complete masking of the bitter taste of the drug and increased the acceptability to volunteers. The compressible non sticky formulations (F1, F3, F4, F5, F6, F7 and F12) were subjected to further evaluation tests after addition of coated desloratadine, including weight uniformity, wetting time, and friability testing.. Fairly good weight uniformity values were observed in all the tested formulations. F12 exhibiting the shortest wetting time (14.7 seconds) and consequently the lowest (20 seconds) disintegration time. Dissolution profile showed that 100% desloratadine release was attained after only 2.5 minutes from the prepared ODT (F12) with dissolution efficiency of 95%.

Keywords: Desloratadine, orally disintegrating tablets (ODTs), formulations, taste masking

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7428 Evidence Based Practice for Oral Care in Children

Authors: T. Turan, Ç. Erdoğan

Abstract:

As far as is known, general nursing care practices do not include specific evidence-based practices related to oral care in children. This study aimed to evaluate the evidence based nursing practice for oral care in children. This article is planned as a review article by searching the literature in this field. According to all age groups and the oral care in various specific situations located evidence in the literature were examined. It has been determined that the methods and frequency used in oral care practices performed by nurses in clinics differ from one hospital to another. In addition, it is seen that different solutions are used in basic oral care, oral care practices to prevent ventilator-associated pneumonia and evidence-based practice in mucositis management in children. As a result, a standard should be established in oral care practices for children and education for children is recommended.

Keywords: evidence-based practice, oral care, nursing, children

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7427 Improving the Accuracy of Oral Care Performed by ICU Nurses for Cancer Patients

Authors: Huang Wei-Yi

Abstract:

Purpose: Oral cancer patients undergoing skin flap reconstruction may have wounds in the oral cavity, leading to accumulation of blood, clots, and secretions. Inadequate oral care by nursing staff can result in oral infections and pain. Methods: An investigation revealed that ICU nurses' knowledge and adherence to oral care standards were below acceptable levels. Key issues identified included lack of hands-on training opportunities, insufficient experience, absence of oral care standards and regular audits, no in-service education programs, and a lack of oral care educational materials. Interventions: The following measures were implemented: 1) in-service education programs, 2) development of care standards, 3) creation of a monitoring plan, 4) bedside demonstration teaching, and 5) revision of educational materials. Results: The intervention demonstrated that ICU nurses' knowledge and adherence to oral care standards improved, leading to better quality oral care and reduced pain for patients. Conclusion: Through in-service education, bedside demonstrations, establishment of oral care standards, and regular audits, the oral care skills of ICU nurses were significantly enhanced, resulting in improved oral care quality and decreased patient pain.

Keywords: oral care, ICU, improving, oral cancer

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7426 Study of Early Diagnosis of Oral Cancer by Non-invasive Saliva-On-Chip Device: A Microfluidic Approach

Authors: Ragini Verma, J. Ponmozhi

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The oral cavity is home to a wide variety of microorganisms that lead to various diseases and even oral cancer. Despite advancements in the diagnosis and detection at the initial phase, the situation hasn’t improved much. Saliva-on-a-chip is an innovative point-of-care platform for early diagnosis of oral cancer and other oral diseases in live and dead cells using a microfluidic device with a current perspective. Some of the major challenges, like real-time imaging of the oral cancer microbes, high throughput values, obtaining a high spatiotemporal resolution, etc. were faced by the scientific community. Integrated microfluidics and microscopy provide powerful approaches to studying the dynamics of oral pathology, microbe interaction, and the oral microenvironment. Here we have developed a saliva-on-chip (salivary microbes) device to monitor the effect on oral cancer. Adhesion of cancer-causing F. nucleatum; subsp. Nucleatum and Prevotella intermedia in the device was observed. We also observed a significant reduction in the oral cancer growth rate when mortality and morbidity were induced. These results show that this approach has the potential to transform the oral cancer and early diagnosis study.

Keywords: microfluidic device, oral cancer microbes, early diagnosis, saliva-on-chip

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7425 The Management of Behcet's Disease Patient's Mandibular Total Edentulism with Custom Made Implant Supported Bar Retainer: A Case Report

Authors: Faruk Emir, Simel Ayyıldız, Cem Şahin

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Behçet’s disease or Behçet’s syndrome is a chronic and multi-systemic inflammatory disease of unknown cause. This syndrome often presents with mucous membrane ulceration and ocular problems. As a systemic disease Behcet includes triple-symptom complex of recurrent oral aphthous ulcers, genital ulcers, and uveitis. Nearly all patients present with some form of painful oral mucocutaneous ulcerations in the form of aphthous ulcers. The aim of the treatment plan for Behçet’s Disease patients is to eliminate oral problems and increase the patient comfort.This clinical report represents the prosthodontic rehabilitation of Behcet’s disease patients mandibular total edentulism with the use of implant supported prosthesis that planned on custom abutments and bar retainers via CAD/CAM technology and patient satisfaction has been achieved in function and aesthetics.

Keywords: Behçet’s disease, CAD/CAM, custom-made manufacturing, titanium milled bar retainer

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7424 Mycophenolate Mofetil Increases Mucin Expression in Primary Cultures of Oral Mucosal Epithelial Cells for Application in Limbal Stem Cell Deficiency

Authors: Sandeep Kumar Agrawal, Aditi Bhattacharya, Janvie Manhas, Krushna Bhatt, Yatin Kholakiya, Nupur Khera, Ajoy Roychoudhury, Sudip Sen

Abstract:

Autologous cultured explants of human oral mucosal epithelial cells (OMEC) are a potential therapeutic modality for limbal stem cell deficiency (LSCD). Injury or inflammation of the ocular surface in the form of burns, chemicals, Stevens Johnson syndrome, ocular cicatricial pemphigoid etc. can lead to destruction and deficiency of limbal stem cells. LSCD manifests in the form of severe ocular surface diseases (OSD) characterized by persistent and recurrent epithelial defects, conjuntivalisation and neovascularisation of the corneal surface, scarring and ultimately opacity and blindness. Most of the cases of OSD are associated with severe dry eye pertaining to diminished mucin and aqueous secretion. Mycophenolate mofetil (MMF) has been shown to upregulate the mucin expression in conjunctival goblet cells in vitro. The aim of this study was to evaluate the effects of MMF on mucin expression in primary cultures of oral mucosal epithelial cells. With institutional ethics committee approval and written informed consent, thirty oral mucosal epithelial tissue samples were obtained from patients undergoing oral surgery for non-malignant conditions. OMEC were grown on human amniotic membrane (HAM, obtained from expecting mothers undergoing elective caesarean section) scaffold for 2 weeks in growth media containing DMEM & Ham’s F12 (1:1) with 10% FBS and growth factors. In vitro dosage of MMF was standardised by MTT assay. Analysis of stem cell markers was done using RT-PCR while mucin mRNA expression was quantified using RT-PCR and q-PCR before and after treating cultured OMEC with graded concentrations of MMF for 24 hours. Protein expression was validated using immunocytochemistry. Morphological studies revealed a confluent sheet of proliferating, stratified oral mucosal epithelial cells growing over the surface of HAM scaffold. The presence of progenitor stem cell markers (p63, p75, β1-Integrin and ABCG2) and cell surface associated mucins (MUC1, MUC15 and MUC16) were elucidated by RT-PCR. The mucin mRNA expression was found to be upregulated in MMF treated primary cultures of OMEC, compared to untreated controls as quantified by q-PCR with β-actin as internal reference gene. Increased MUC1 protein expression was validated by immunocytochemistry on representative samples. Our findings conclude that OMEC have the ability to form a multi-layered confluent sheet on the surface of HAM similar to a cornea, which is important for the reconstruction of the damaged ocular surface. Cultured OMEC has stem cell properties as demonstrated by stem cell markers. MMF can be a novel enhancer of mucin production in OMEC. It has the potential to improve dry eye in patients undergoing OMEC transplantation for bilateral OSD. Further clinical trials are required to establish the role of MMF in patients undergoing OMEC transplantation.

Keywords: limbal stem cell deficiency, mycophenolate mofetil, mucin, ocular surface disease

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7423 Nano-emulsion/Nano-suspension as Precursors for Oral Dissolvable Film to Enhance Bioavalabilty for Poor-water Solubility Drugs

Authors: Yuan Yang, Mickey Lam

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Oral dissolvable films have been considered as a unique alternative approach to conventional oral dosage forms. The films could be administrated via the gastrointestinal tract as conventional dosages or through sublingual/buccal mucosa membranes, which could enhance drug bioavailability by avoiding the first-pass effect and improving permeability due to high blood flow and lymphatic circulation. This work has described a state-of-art technic using nano-emulsion/nano-suspension as a precursor for the film to enhance the bioavailability of BCS class II drugs. The drug molecules are consequentially processed through the emulsification, gelation, and film-casting processes. The gelation process is critical to stabilizing the nano-emulsion for the film-casting as well as controlling the drug release process. Furthermore, the size of the nanoparticle on the film has a strong correlation with the size of the micelles in the precursor and the condition of the gelation process. It has been discovered that nanoparticle from 200 nm to 300 nm has shown the highest permeability for sublingual administration. In one example shown in work, the bioavailability of a low solubilize drug has been increased from 10% to 24% via sublingual administration of the film. The increasing of the bioavailability was thought to be associated with the enhancement of the diffusion process of the drug in the saliva layer above the mucosa membrane and the fact that the presents of the emulsifier help lose the rigid junction of the mucosa cells.

Keywords: oral dissolvable film, nano-suspension, nano-emulsion, bioavailability

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7422 A Lost Tradition: Reflections towards Select Tribal Songs of Odisha

Authors: Akshaya K. Rath, Manjit Mahanta

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The paper aims at examining the oral tradition of the Kondh and Oroan people of Odisha. Highlighting the translated versions of Kondh and Oroan songs—chiefly highlighting issues on agriculture—we argue that the relevance of these songs have fallen apart in the recent decades with the advancement of modern knowledge and thinking. What remains instead is a faint voice in the oral tradition that sings the past indigenous knowledge in the form of oral literature. Though there have been few attempts to document the rich cultural tradition by some individuals—Sitakant Mahapatra’s can be cited as an example—the need to document the tradition remains ever arching. In short, the thesis examines Kondh and Oroan “songs” and argues for a need to document the tradition. It also shows a comparative study on both the tribes on Agriculture which shows their cultural identity and a diversification of both the tribes in nature and how these tribal groups are associated with nature and the cycle of it.

Keywords: oral tradition, Meriah, folklore, karma, Oroan

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7421 Prevalence of Oral Mucosal Lesions in Malaysia: A Teaching Hospital Based Study

Authors: Renjith George Pallivathukal, Preethy Mary Donald

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Asymptomatic oral lesions are often ignored by the patients and usually will be identified only in advanced stages. Early detection of precancerous lesions is important for better prognosis. It is also important for the oral health care person to be aware of the regional prevalence of oral lesions in order to provide early care for the same. We conducted a retrospective study to assess the prevalence of oral lesions based on the information available from patient records in a teaching dental school. Dental records of patients who attended the department of Oral medicine and diagnosis between September 2014 and September 2016 were retrieved and verified for oral lesions. Results: The ages of the patients ranged from 13 to 38 years with a mean age of 21.8 years. The lesions were classified as white (40.5%), red (23%), ulcerated (10.5%), pigmented (15.2%) and soft tissue enlargements (10.8%). 52% of the patients were unaware of the oral lesions before the dental visit. Overall, the prevalence of lesions in dental patients lower to national estimates, but the prevalence of some lesions showed variations.

Keywords: oral mucosal lesion, pre-cancer, prevalence, soft tissue lesion

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7420 Bcl-2: A Molecule to Detect Oral Cancer and Precancer

Authors: Vandana Singh, Subash Singh

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Introduction: Oral squamous cell carcinoma is the most common malignant tumor of the oral cavity. Normally the death of cell and the growth are active processes and depend not only on external factors but also on the expression of genes like Bcl-2, which activate and inhibit apoptosis. The term Bcl-2 is an acronym for B-cell lymphoma/ leukemia -2 genes. Objectives: An attempt was made to evaluate Bcl-2 oncoprotein expression in patients with oral precancer and cancer and to assess possible correlation between Bcl-2 oncoprotein expression and clinicopathological features of oral precancer and cancer. Material and Methods: This is a selective prospective clinical and immunohistochemical study. Clinicopathological examination is correlated with immunohistochemical findings. The immunolocalization of Bcl-2 protein is performed using the labeled streptavidin biotin (LSAB) method. To visualize the reaction, 3, 3-diaminobenzidine (DAB) is used. Results: Bcl-2 expression was positive in 11 [36.66 %, low Bcl-2 expression 3 (10.00 %), moderate Bcl-2 expression 7 (23.33 %), and high Bcl-2 expression 1 (3.33 %)] oral cancer cases and in 14 [87.50 %, low expression 8 (50 %), moderate expression 6 (37.50 %)] precancer cases. Conclusion: On the basis of the results of our study we conclude that positive Bcl-2 expression may be an indicator of poor prognosis in oral cancer and precancer. Relevance: It has been reported that there is deregulation of Bcl-2 expression during progression from oral epithelial dysplasia to squamous cell carcinoma. It can be used for revealing progression of epithelial dysplasia to malignancy and as a prognostic marker in oral precancer and cancer.

Keywords: BcL-2, immunohistochemistry, oral cancer, oral precancer

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7419 Application of Response Surface Methodology (RSM) for Optimization of Fluoride Removal by Using Banana Peel

Authors: Pallavi N., Gayatri Jadhav

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Good quality water is of prime importance for a healthy living. Fluoride is one such mineral present in water which causes many health problems in humans and specially children. Fluoride is said to be a double edge sword because lesser and higher concentration of fluoride in drinking water can cause both dental and skeletal fluorosis. Fluoride is one of the important mineral usually present at a higher concentration in ground water. There are many researches being carried out for defluoridation method. In the present research, fluoride removal is demonstrated using banana peel which is a biowaste as a biocoagulant. Response Surface Methodology (RSM) is a statistical design tool which is used to design the experiment. Central Composite Design (CCD) was used to determine the influence of the pH and dosage of the coagulant on the optimal removal of fluoride from a simulated water sample. 895 of fluoride removal were obtained in a acidic pH range of 4 – 9 and bio coagulant dosage of dosage of 18 – 20mg/L.

Keywords: Fluoride, Response Surface Methodology, Dosage, banana peel

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7418 Stability Indicating RP – HPLC Method Development, Validation and Kinetic Study for Amiloride Hydrochloride and Furosemide in Pharmaceutical Dosage Form

Authors: Jignasha Derasari, Patel Krishna M, Modi Jignasa G.

Abstract:

Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product.Stability testing data provides the basis to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors. Besides this, it also helps in selecting proper formulation and package as well as providing proper storage conditions and shelf life, which is essential for regulatory documentation. The ICH guideline states that stress testing is intended to identify the likely degradation products which further help in determination of the intrinsic stability of the molecule and establishing degradation pathways, and to validate the stability indicating procedures. A simple, accurate and precise stability indicating RP- HPLC method was developed and validated for simultaneous estimation of Amiloride Hydrochloride and Furosemide in tablet dosage form. Separation was achieved on an Phenomenexluna ODS C18 (250 mm × 4.6 mm i.d., 5 µm particle size) by using a mobile phase consisting of Ortho phosphoric acid: Acetonitrile (50:50 %v/v) at a flow rate of 1.0 ml/min (pH 3.5 adjusted with 0.1 % TEA in Water) isocratic pump mode, Injection volume 20 µl and wavelength of detection was kept at 283 nm. Retention time for Amiloride Hydrochloride and Furosemide was 1.810 min and 4.269 min respectively. Linearity of the proposed method was obtained in the range of 40-60 µg/ml and 320-480 µg/ml and Correlation coefficient was 0.999 and 0.998 for Amiloride hydrochloride and Furosemide, respectively. Forced degradation study was carried out on combined dosage form with various stress conditions like hydrolysis (acid and base hydrolysis), oxidative and thermal conditions as per ICH guideline Q2 (R1). The RP- HPLC method has shown an adequate separation for Amiloride hydrochloride and Furosemide from its degradation products. Proposed method was validated as per ICH guidelines for specificity, linearity, accuracy; precision and robustness for estimation of Amiloride hydrochloride and Furosemide in commercially available tablet dosage form and results were found to be satisfactory and significant. The developed and validated stability indicating RP-HPLC method can be used successfully for marketed formulations. Forced degradation studies help in generating degradants in much shorter span of time, mostly a few weeks can be used to develop the stability indicating method which can be applied later for the analysis of samples generated from accelerated and long term stability studies. Further, kinetic study was also performed for different forced degradation parameters of the same combination, which help in determining order of reaction.

Keywords: amiloride hydrochloride, furosemide, kinetic study, stability indicating RP-HPLC method validation

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7417 Community Perception and Knowledge on Oral Cancer Screening Methods in Kuwait

Authors: Lavanya Dharmendran, Shenuka Singh, Sona Baburathanam

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The aim of the study is to understand the level of awareness in a community of a specific region of Kuwait regarding oral cancer and its screening methods so as to enhance the uptake of oral cancer screening methods. This is a cross-sectional study comprising 100 adult participants residing in the governate of Farwaniya, Kuwait. Participants of above 18 years of both genders will be selected using convenience sampling. Data collection includes the administration of a self-administered questionnaire. The questionnaire comprises three sections, each section assessing the knowledge, attitudes and practices of the participants’ opinions about oral cancer and screening methods. Data will be analyzed using Humphris Oral Cancer Knowledge Scale. Inferential statistics will be done using Chi-Square or Fisher’s exact test for categorical data. A level of p<.05 will be established as being significant. All ethical considerations, such as respect for personal confidentiality and informed consent, will be applied in this study. This study revealed that although respondents were aware of the term oral cancer, more than half of the study participants were unaware of the symptoms associated with this condition. Smoking and alcohol were identified as risk factors for oral cancer, but the majority of participants did not identify the Human Papilloma Virus (HPV) as an added risk factor. This suggests a greater need for dental practitioners to include educational strategies in routine dental visits to ensure greater awareness of oral cancer.

Keywords: oral cancer, oral screening, oral public health, oral health

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7416 Oral Lichen Planus a Manifestation of Grinspan's Syndrome or a Lichenoid Reaction to Medication

Authors: Sahar Iqrar, Malik Adeel Anwar, Zain Akram, Maria Noor

Abstract:

Introduction: Oral lichen planus is a chronic inflammatory condition of unknown etiology. Oral lichen planus may be related with several other diseases. Grinspan's Syndrome is characterized by a triad of oral lichen planus, hypertension, and diabetes mellitus. Other associations reported in the literature are with chronic liver disease and, with dyslipidemia. The nature of these associations is still not fully understood. Material and methods: Study was conducted in Department of Oral Medicine, Fatima Memorial Hospital College of Medicine and Dentistry, Lahore, Pakistan. A total of n=89 clinically diagnosed patients of oral lichen planus of both gender and all age groups were recruited and detailed history were recorded in the designed performs. Results: A total of n=89 patients were taken with male to female ratio of 3:8 in which 24 were male and 65 females. Mean age was 48.8 ± 13.8 years. Age range of 10-74 years was seen. Among these patients suffering from oral lichen planus, 41.6% (n=37) had a positive history for hypertension with 59.5% (n=22) of these patients were taking different medication for their condition. Whereas Diabetes Mellitus was found in 24.7% (n=22) patients with 72.7% (n=16) of these patients using the hypoglycemic drug (oral or injectable) to control their blood glucose levels. Out of these n=89 lichen planus patients 21.3% had both hypertension and diabetes mellitus (fulfilling the criteria for Grinspan's Syndrome). Out of this Grinspan's Syndrome pool 94.7% (n=19) were taking drug atleast for one of the two conditions. Conclusion: As noticed form the medical history of the patients, most of them were using hypoglycemic drugs for diabetes mellitus and beta blockers, diuretics and calcium channel blockers for hypertension. These drugs are known for lichenoid reaction. Therefore, it should be ruled out at histopathological/ immunological and molecular level whether these patients are suffering from lichen planus or lichenoid drug reaction to truly declare them as patients with Grinspan’s Syndrome.

Keywords: diabetes mellitus, grinspan's syndrome, lichenoid drug reaction, oral lichen planus

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7415 Stability Indicating Method Development and Validation for Estimation of Antiasthmatic Drug in Combined Dosages Formed by RP-HPLC

Authors: Laxman H. Surwase, Lalit V. Sonawane, Bhagwat N. Poul

Abstract:

A simple stability indicating high performance liquid chromatographic method has been developed for the simultaneous determination of Levosalbutamol Sulphate and Ipratropium Bromide in bulk and pharmaceutical dosage form using reverse phase Zorbax Eclipse Plus C8 column (250mm×4.6mm), with mobile phase phosphate buffer (0.05M KH2PO4): acetonitrile (55:45v/v) pH 3.5 adjusted with ortho-phosphoric acid, the flow rate was 1.0 mL/min and the detection was carried at 212 nm. The retention times of Levosalbutamol Sulphate and Ipratropium Bromide were 2.2007 and 2.6611 min respectively. The correlation coefficient of Levosalbutamol Sulphate and Ipratropium Bromide was found to be 0.997 and 0.998.Calibration plots were linear over the concentration ranges 10-100µg/mL for both Levosalbutamol Sulphate and Ipratropium Bromide. The LOD and LOQ of Levosalbutamol Sulphate were 2.520µg/mL and 7.638µg/mL while for Ipratropium Bromide was 1.201µg/mL and 3.640 µg/mL. The accuracy of the proposed method was determined by recovery studies and found to be 100.15% for Levosalbutamol Sulphate and 100.19% for Ipratropium Bromide respectively. The method was validated for accuracy, linearity, sensitivity, precision, robustness, system suitability. The proposed method could be utilized for routine analysis of Levosalbutamol Sulphate and Ipratropium Bromide in bulk and pharmaceutical capsule dosage form.

Keywords: levosalbutamol sulphate, ipratropium bromide, RP-HPLC, phosphate buffer, acetonitrile

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7414 Development of Methotrexate Nanostructured Lipid Carriers for Topical Treatment of Psoriasis: Optimization, Evaluation, and in vitro Studies

Authors: Yogeeta O. Agrawal, Hitendra S. Mahajan, Sanjay J. Surana

Abstract:

Methotrexate is effective in controlling recalcitrant psoriasis when administered by the oral or parenteral route long-term. However, the systematic use of this drug may provoke any of a number of side effects, notably hepatotoxic effects. To reduce these effects, clinical studies have been done with topical MTx. It is useful in treating a number of cutaneous conditions, including psoriasis. A major problem in topical administration of MTx currently available in market is that the drug is hydrosoluble and is mostly in the dissociated form at physiological pH. Its capacity for passive diffusion is thus limited. Localization of MTx in effected layers of skin is likely to improve the role of topical dosage form of the drug as a supplementary to oral therapy for treatment of psoriasis. One of the possibilities for increasing the penetration of drugs through the skin is the use of Nanostructured lipid Carriers. The objective of the present study was to formulate and characterize Methotrexate loaded Nanostructured Lipid Carriers (MtxNLCs), to understand in vitro drug release and evaluate the role of the developed gel in the topical treatment of psoriasis. MtxNLCs were prepared by solvent diffusion technique using 3(2) full factorial design.The mean diameter and surface morphology of MtxNLC was evaluated. MtxNLCs were lyophilized and crystallinity of NLC was characterized by Differential Scanning Calorimtery (DSC) and powder X-Ray Diffraction (XRD). The NLCs were incorporated in 1% w/w Carbopol 934 P gel base and in vitro skin deposition studies in Human Cadaver Skin were conducted. The optimized MtxNLCs were spherical in shape, with average particle size of 253(±9.92)nm, zeta potential of -30.4 (±0.86) mV and EE of 53.12(±1.54)%. DSC and XRD data confirmed the formation of NLCs. Significantly higher deposition of Methotrexate was found in human cadaver skin from MtxNLC gel (71.52 ±1.23%) as compared to Mtx plain gel (54.28±1.02%). Findings of the studies suggest that there is significant improvement in therapeutic index in treatment of psoriasis by MTx-NLCs incorporated gel base developed in this investigation over plain drug gel currently available in the market.

Keywords: methotrexate, psoriasis, NLCs, hepatotoxic effects

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7413 Effect of Polarized Light Therapy on Oral Mucositis in Cancer Patients Receiving Chemotherapy

Authors: Zakaria Mowafy Emam Mowafy, Hamed Abd Allah Hamed, Marwa Mahmoud Abd-Elmotalb, Andrew Anis Fakhray Mosaad

Abstract:

The purpose of this paper is to determine the efficacy of polarized light therapy for chemotherapy-treated cancer patients who have oral mucositis. Methods of evaluation are the measurement of the WHO oral mucositis scale and the common toxicity criteria scale. Methods: Thirty cancer patients receiving chemotherapy (males and females) who had oral mucositis and ulceration pain, and their ages ranged from 30 to 55 years, were divided into two groups. Group (A), composed of 15 patients, received the Bioptron light therapy (BLT) in addition to the routine medical care of oral mucositis. Group (B) received only the routine medical care of oral mucositis; the duration of the BLT application was 10 minutes applied daily for 30 days. Results and conclusion: Results showed that the application of the BLT had valuable healing effects on oral mucositis in cancer patients receiving chemotherapy, as evidenced by the high decreases of the WHO oral mucositis scale and the common toxicity criteria scale.

Keywords: Bioptron light therapy, oral mucositis, WHO oral mucositis scale, common toxicity criteria scale

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7412 3D Printing of Dual Tablets: Modified Multiple Release Profiles for Personalized Medicine

Authors: Veronika Lesáková, Silvia Slezáková, František Štěpánek

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Additive manufacturing technologies producing drug dosage forms aimed at personalized medicine applications are promising strategies with several advantages over the conventional production methods. One of the emerging technologies is 3D printing which reduces manufacturing steps and thus allows a significant drop in expenses. A decrease in material consumption is also a highly impactful benefit as the tested drugs are frequently expensive substances. In addition, 3D printed dosage forms enable increased patient compliance and prevent misdosing as the dosage forms are carefully designed according to the patient’s needs. The incorporation of multiple drugs into a single dosage form further increases the degree of personalization. Our research focuses on the development of 3D printed tablets incorporating multiple drugs (candesartan, losartan) and thermoplastic polymers (e.g., KlucelTM HPC EF). The filaments, an essential feed material for 3D printing,wereproduced via hot-melt extrusion. Subsequently, the extruded filaments of various formulations were 3D printed into tablets using an FDM 3D printer. Then, we have assessed the influence of the internal structure of 3D printed tablets and formulation on dissolution behaviour by obtaining the dissolution profiles of drugs present in the 3D printed tablets. In conclusion, we have developed tablets containing multiple drugs providing modified release profiles. The 3D printing experiments demonstrate the high tunability of 3D printing as each tablet compartment is constructed with a different formulation. Overall, the results suggest that the 3D printing technology is a promising manufacturing approach to dual tablet preparation for personalized medicine.

Keywords: 3D printing, drug delivery, hot-melt extrusion, dissolution kinetics

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7411 “Voiceless Memory” and Holodomor (Great Famine): The Power of Oral History to Challenge Official Historical Discourse

Authors: Tetiana Boriak

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The study is called to test correlation between official sources, preserved in the archives, and “unofficial” oral history regarding the Great Famine of 1932–1933 in Ukraine. The research shows poor preservation of the sources, being deliberately destroyed by the totalitarian regime. It involves analysis of five stages of Holodomor oral history development. It is oral history that provides the mechanism of mass killing. The research proves that using only one type of historical sources leads to a certain line of reading history of the Holodomor, while usage of both types provides in-depth insight in the history of the famine.

Keywords: the Holodomor (the Great Famine), oral history, historical source, historical memory, totalitarianism.

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7410 Oral Health of Tobacco Chewers: A Cross-Sectional Study in Karachi, Pakistan

Authors: Warsi A. Ibrahim, Qureshi A. Ambrina, Younus M. Anjum

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Introduction: Oral lesions related to commercially available Smokeless Tobacco (ST), such as, Pan, Gutka, Mahwa, Naswar is considered a serious challenge for dental health care providers in Pakistan. Majority of labored Pakistani population consume ST, where public transporters and drivers are no exception. It was necessary to identify individuals of this particular population group and screen their oral health and early signs of pre-cancerous lesions so that appropriate preventive measures could be taken to reduce the burden on health providers. Aim of Study: To estimate Prevalence of ST consumption and perception of use, and to evaluate Oral Health status among public drivers of Karachi. Material & methods: A cross-sectional study survey was conducted over duration of 2 months, through convenient sampling. Sample size (n=615) of public drivers (age > 18 years) all over Karachi was gathered. A structured proforma was used to record socio-demographics, addiction profile, perception of use and oral health status (oral lesions, oral sub-mucosal fibrosis and dental caries) of study participants. Data was entered and analyzed using SPSS version 16.0 using descriptive statistics only. Results: Prevalence of ST consumption among the study participants was figured to 92.5%. Out of these almost 70% suffered from one or the other form of oral lesion(s). Four major types of ST consumption were observed out of which 60 % of oral lesion were related to Gutka chewers showing early signs of oral cancer. In addition, occurrence of Oral sub-mucosal fibrosis (OSF) was found to be significantly high around 54.8%. Overall dental caries status was also high, showing on an average 5 teeth of an individual were decayed, missing or filled deviating from WHO normal criteria (mean < 3). It was thus proven from the study that public drivers relied on oral tobacco consumption because it helps them ‘Improve consciousness’ (p-value: < 0.01; using chi-square test). Multivariate analysis showed that there were higher prevalence of smokeless tobacco among highway drivers versus local drivers (A.O.R: 2.82 [0.83-9.61], p-value: < 0.01) Conclusion: Smokeless tobacco (ST) consumption has a direct effect on oral health. However, the type of ST, the duration of consumption are factors which are directly related to the severity. Moreover, Gutka may be considered as having most lethal effects on oral health which may lead to oral cancer and affect individual’s quality of life. Specific preventive programs must be undertaken to reduce the consumption of Gutka among public transporters and drivers.

Keywords: smokeless tobacco, oral lesions, drivers, public transporters

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7409 Oral Sex Practice among Men Who Have Sex with Men: A Cross-Sectional Study in Indonesian Urban Settings

Authors: I Putu Yuda Hananta, Inke Kusumastuti

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The latest Indonesian Biology and Behavior Surveillance (IBBS) conducted by Indonesian Ministry of Health reported a large proportion of men who have sex with men (MSM) engaging in oral sex in their recent sexual history. While it is considered as a pleasuring and safe, oral sex might facilitate the transmission of various sexually transmitted infection (STI) pathogens. This study was aimed to investigate the oral sex practice among MSM in Indonesian urban settings to help delineate demographic and behavior determinants of such practice. In 2014, 501 MSM in 8 clinic-based and outreach STI services were recruited in Jakarta, Yogyakarta and Denpasar, Indonesia. Respondents completed a self-administered questionnaire inquiring about their demographics and sexual history. Median age (interquartile range) of the respondents was 27 (24-30) years; most completed senior high school (54.3%), worked in informal jobs (57.9%), and single (60.9%); and 32.3% reported receiving money in exchange for sex. Oral sex was practiced by most respondents: insertive only (10.0%), receptive only (6.0%), and both (82.4%). A separate multivariable analysis was performed using logistic regression to identify the determinants for receptive and insertive oral sex. Factors associated with receptive oral sex were having more than 10 sex partner(s) in the preceding 6 months vs 1 partner, adjusted odds ratio (aOR) [95% CI]=3.40 [1.22-9.42], p=0.03; and history of receptive-insertive anal sex vs no history, aOR=4.37 [1.76-10.82], p=0.01. Factors associated with insertive oral sex were receiving money for sex vs. not receiving, aOR=2.98 [1.10-8.04], p=0.02; and history of receptive-insertive anal sex vs. no history, aOR=2.10 [0.51-8.74], p<0.001. Only a few respondents reported consistent condom use (11.6% and 12.0% for receptive and insertive oral sex, respectively). Our findings demonstrated that while oral sex is a common practice among MSM, the consistency of condom use in oral sex is very low. In addition, certain sex behavior (number of sex partners, sex work and history of anal sex) were associated with oral sex, and this might need to be addressed during health promotion efforts on STI prevention through oral-genital contact.

Keywords: behavior, Indonesia, men who have sex with men, oral sex

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7408 Correlation Between HIV/AIDS Stage With Oral Health, Dentition, and Periodontal Status

Authors: Eriselda Simoni, Leonard Simoni, Endri Paparisto, Laureta Flaga, Silvana Bara, Edit Xhajanka, Arjan Harxhi

Abstract:

Background: Some pathologies are encountered more often in HIV/ AIDS, such as those with bacterial, fungal, viral, and neoplastic causes, but what has been more noticeable in recent years is the increased and more aggressive manifestation of periodontal disease and oral caries. Our purpose is to investigate the correlation between the HIV/AIDS stage and CD4 level with oral health, dentition, and periodontal status. Materials and Methods: We conducted a prospective observational study that included 35 patients newly diagnosed with HIV/AIDS and underwent an oral examination at the University Dental Clinic in Tirana, Albania, in the period April - July 2024. This study evaluated the basic demographic, laboratory characteristics, oral hygiene, and the presence of oral lesions. The dentition status was assessed with the values DT (decay teeth), FT (filled teeth), and MT (missing teeth) presented as DMFT. The periodontal status was evaluated through a periodontal probe measuring CPI (community periodontal index) and LOA (loss of attachment) as recommended by the WHO Oral Health Assessment Form 2013. The Pearson Correlation Coefficient (r) was used to evaluate the relationship between levels of CD4+ and DMF, CD4+ and CPI, and CD4+ and LOA. The P value ≤ 0.05 was considered statistically significant. Results: 80% of patients included were males with a mean age of 35.8 years. 8.6% of patients were categorized as HIV stage I, 28.6% as stage II, and 62.8% as HIV stage III/AIDS. The mean level value of CD4+ was 266.2 cells/mm3 and the rapport CD4+/ WBC (White Blood Cells) was 15.7%. Most patients (57.2%) used toothbrushes less than 1 time a day. An important negative correlation was found between CD4+ and dentition and periodontal status. A lower level of CD4+ was correlated with a higher DMFT, CPI, and LOA, respectively coefficient (r) for CD4/DMFT = -0.52, p =0.01, (r) for CD4/CPI= - 0.38, p=0.024 and (r) for CD4/LOA= - 0.37, p=0.029. Conclusions: In our study, it was documented that patients with HIV/AIDS had worse oral health, an important negative correlation between CD4+ and dentition and periodontal status. A lower level of CD4+ was correlated with a worse dentition status (higher DMFT), and poor periodontal health (higher CPI and LOA). The monitoring and treatment of oral pathologies can be important in early HIV/AIDS diagnoses and treatment.

Keywords: HIV/AIDS, oral health, dentition, periodontal

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