Title of the project: Prevalence of Oral Mucosal Abnormalities, Associated risk factors, and Quality of Life in Older Indian Adults: A Cross-sectional Study

2. Type of Study: Prospective study- cross sectional study

3. Aims & objectives (hypotheses if applicable): Aim: To determine the prevalence of oral mucosal abnormalities among older adult patients attending the OPD of MCODS, Manipal, India, associated risk factors, and their quality of life. Objective: 1) To determine the prevalence and distribution of oral mucosal abnormalities in older adult population visiting Dental OPD. 2) To determine the common risk factors associated with the study population with oral mucosal abnormalities and compare it with the population without oral mucosal abnormalities. 3) To assess the quality of life in the older adult population with chronic oral mucosal abnormalities using the COMDQ-15 questionnaire

4. Justification for study (whether of national significance with rationale): This study is pertinent because even though there are many published studies on oral health in the older adult population, there has not been much data available on the prevalence of oral mucosal abnormalities, especially in India. The information provided by our study will contribute to the epidemiologic data pool of older adults in India. There are very few studies that have assessed the association of risk factors with mucosal conditions and the information provided from our study can help in educating the patients and providing personalized preventive instructions and better care. This study will also help us to understand the perception of the older age group towards oral mucosal abnormalities and how it affects the mental well-being and overall quality of life in this vulnerable group. This study can help public health efforts to reduce the burden of oral diseases in older people and we could contribute to plans and programs aimed at preventing and managing these lesions in older adults.

5. Departments involved: Department of Oral Medicine & Radiology- Manipal College of Dental Sciences, Manipal, Karnataka.

6. Study period: 2 years (Till March 2026)

7. Sample size:: To estimate the prevalence of oral mucosal abnormalities in older adults with 95% confidence level, anticipated prevalence of 50% and 5% margin of error.

8. Materials and methods:

a) INCLUSION CRITERIA: 1) All patients aged 60 years and above visiting the Department of Oral Medicine and Radiology. 2) Patients who provided consent to participate in the study. 3). Patients should be able to understand and complete questionnaires. EXCLUSION CRITERIA: 1) Patients below 60 years of age 2) Patients with neurological conditions that make it difficult to understand the information 3) Patients who do not provide their consent 4) Inadequate Mouth Opening for detailed oral

examination 5) Patients who underwent recent maxillofacial trauma (< 3 months). 6) Patient undergoing orofacial radiotherapy 7) Patients suffering from severe systemic disease (ASA 3 or more) and/or some psychiatric conditions that might affect the participation of the study such as schizophrenia.

b) Biological materials required : Yes ☐ No ☒

c) Statistical methods: Descriptive statistics will be used. The comparisons with risk factors and quality of life will be done using the Chi-Square test.

d) Tools used: COMDQOL-15 is the tool given for assessing the Quality of life. The permission is obtained from the author through Mail. The COMDQ-15 has exhibited good reliability (Cronbach’s α: 0.7 to 0.91) and criterion validity, correlating strongly with the original COMDQ. It serves as a concise, valid, and reliable tool for evaluating the quality of life in chronic oral mucosal conditions, aiding clinicians in patient assessment. 9. Detailed description of procedure / processes: The selection process for participants in this study includes individuals aged 60 years and above who are visiting the Department of Oral Medicine and Radiology and have consented to participate in the research. It’s crucial that participants possess the ability to understand and complete questionnaires to ensure the reliability of the data collected. Before the study can commence, the research protocol undergoes a thorough review by both the department and institutional research committee to uphold scientific rigor and ethical standards. Following internal scrutiny, the protocol is submitted to the KH Institutional Ethics Committee for final approval, which includes clearance from regulatory bodies like the Clinical Trials Registry - India (CTRI). Once all necessary approvals are obtained, the data collection phase of the study will begin. Participants will be carefully selected based on predefined criteria established by the research team. Upon selection, they will be provided with a comprehensive patient information sheet (in English and Kannada depending on the patient’s preferred language) detailing the study’s objectives, procedures, and potential risks. This empowers participants to make informed decisions about their participation, and informed consent (will be available in both English and Kannada) will be obtained from each participant to ensure voluntary participation and understanding of the study’s parameters. The data collection process will begin with a detailed case history and examinations of participants, including gathering demographic information, medical history including systemic illnesses and medications, oral abusive habits, denture usage, and sleep pattern using a structured proforma. Clinical examinations will be conducted under standardized conditions following WHO guidelines, aiming to identify various oral mucosal abnormalities such as red and white lesions, pigmented lesions, ulcerative lesions, oral cancer, and benign tumors. Abnormalities will be meticulously classified based on clinical criteria, and if

malignancy is suspected, histopathological examinations will be conducted to confirm diagnosis. In addition to clinical assessments,(all the clinical assessments including histopathology are standard of care) participants will be administered the COMDQ-15 questionnaire to evaluate their oral health-related quality of life, providing subjective insights into how oral health issues impact their daily lives. Data collection will involve documentation of the presence or absence of oral mucosal abnormalities as binary outcome variables, along with detailed notes on the number, pattern, and distribution of abnormalities on a designated data collection sheet. After collecting the data, we will use statistical analysis to investigate possible associations between different factors, such as age, gender, habits, systemic diseases, denture usage, and clinical diagnoses of oral abnormalities. We will also analyze how oral health problems affect various aspects of participants’ quality of life and compare them with people who do not have any abnormalities.

10. Outcome measures: The primary outcome measure involves determining the frequency and distribution of various oral mucosal abnormalities, including red and white patches, ulcers, pigmented lesions, and oral cancer. Concurrently, associated factors associated with the presence of these abnormalities, such as age, gender, habits (e.g., tobacco or alcohol use), systemic diseases, medications, and denture usage. Additionally, the Chronic Oral Mucosal Disease Questionnaire (COMDQ-15) outcomes to evaluate participants’ oral health-related quality of life, encompassing aspects such as pain, discomfort, functional limitations, and psychological effects and comparing between people with and without mucosal abnormalities. By meticulously examining these outcome measures, the study seeks to provide comprehensive insights into the prevalence, associated risk factors, and impact on the quality of life of oral mucosal abnormalities among older Indian adults.

11. Potential risks and benefits: Benefits- The study will provide crucial insights for healthcare planning and interventions by understanding the frequency and distribution of oral mucosal abnormalities. By pinpointing risk factors like smoking and poor oral hygiene, preventive measures can be implemented. Early detection enables timely interventions, reducing the risk of severe conditions like oral cancer and improving health outcomes. Policymakers can use findings to tailor oral health programs for older adults, addressing their specific needs and enhancing overall well-being. Additionally, filling knowledge gaps is essential for informed decision-making, while educational efforts raise awareness about oral health maintenance and screening, ultimately contributing to promoting oral health and enhancing the quality of life among older adults in India. Incidental findings of this study could cause psychological distress, anxiety, or fear in elderly individuals. The stigma associated with oral health

problems or the anticipation of undergoing invasive procedures may exacerbate mental health issues in this vulnerable population.

12. Ethical considerations and methods to address issues: IEC clearance. Consenting and permissions will be taken, and confidentiality of the data will be maintained.

13. Budget (give details) and proposed funding source: Rs 3000- self-funded. For stationery – printing of consent forms and participation sheets

14. Review of literature (within 1000 words): [1] A study conducted by Cheruvathoor et al. aimed to determine the prevalence, pattern, and distribution of oral mucosal lesions in geriatric patients in Kerala, India. The study involved 750 participants aged 60 and above and revealed a high prevalence of oral mucosal lesions (59.6%). Age over 65, male gender, presence of habits, and denture usage were significantly associated with these lesions. The study highlights the need for geriatric dental clinics with tailored interventions to improve the oral health and overall well-being of geriatric populations.[2] Patil, Doni, and Maheshwari conducted a study on oral mucosal lesions in 5,100 elderly Indian patients aged 60 to 98 years, revealing a 64% prevalence. Lesions were associated with tobacco and betel nut use, trauma, and prosthetic use. While males were more affected, gender difference was not significant clinically. Common lesions included smoker’s palate, denture stomatitis, and oral submucous fibrosis, among others, with the hard palate being most affected. The study emphasizes the need for systematic evaluation and tailored oral health interventions in geriatric Indian patients, offering valuable insights for clinicians and researchers in addressing oral health issues in this demographic.[3] A clinical study conducted by Dundar et al in Turkey investigated the prevalence of oral mucosal conditions (OMC) in 700 elderly individuals. The study found that 40.7% of the participants had OMC. Factors such as male gender, length of denture use, smoking, and former smoking were significant predictors of OMC. Smoking was also found to be associated with an increased risk of leukoplakia. The study emphasizes the need for customized preventive strategies in geriatric dental care, given the significant prevalence and risk factors of OMC in this demographic.[4] Bozdemir et al. investigated oral mucosal lesions in 709 elderly dental patients, revealing a high prevalence of 87.6%. While gender did not impact prevalence significantly, age groups showed variation. Sublingual varicosity was the most common lesion. Associations were found with systemic diseases, denture use, and smoking, particularly as predictive factors. The study stresses the importance of regular oral exams for early detection, especially among the elderly, smokers, and denture wearers, emphasizing the need for proactive oral health strategies in this population.[5] Wiriyakijja et al. developed and validated a shorter version of the Chronic Oral Mucosal Disease Questionnaire (COMDQ-15) to alleviate patient burden. Through analysis of 520 patients, they conducted item reduction and factor analysis, resulting in a 15-item questionnaire with four consistent factors. Confirmatory factor analysis supported the structure’s validity. The COMDQ-15 exhibited good reliability (Cronbach’s α: 0.7 to 0.91) and criterion validity, correlating

strongly with the original COMDQ. It serves as a concise, valid, and reliable tool for evaluating the quality of life in chronic oral mucosal conditions, aiding clinicians in patient assessment.[6] Rajan et al. conducted a prospective study on 70 patients with chronic oral mucosal diseases (COMD), using the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) to assess their quality of life (QOL). COMD, including conditions like oral lichen planus and pemphigus, impose significant physical, social, and psychological burdens. Patients over 35 reported lower QOL in social and emotional domains, while men reported better oral health-related QOL than women, particularly in pain and functional limitation. Differences in overall QOL were noted among disease groups, with pemphigus patients experiencing the poorest QOL. The study emphasizes the ongoing negative impact of COMD on QOL even after treatment, highlighting the importance of continuous QOL assessment in clinical management using specialized instruments like the COMDQ