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临床试验/CTRI/2024/10/075263
CTRI/2024/10/075263招募中不适用

Prevalence And Severity of Non-Carious Cervical Lesions in Adult Population and Evaluation of the Potential Risk Factors Associated With it – A Cross Sectional Study

Gaurav Kulkarni1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Non-Carious Cervical Lesions

研究概览

简要总结

What is the prevalence and severity of NCCL in the population visiting a dental hospital in Navi Mumbai? Is there an association between salivary characteristics and the incidence of NCCL? Aim: - To estimate the prevalence and severity of NCCL in adults visiting a dental hospital in Navi Mumbai and evaluate the potential risk factors associated with the condition.

Objectives: -

  1. To estimate the prevalence of NCCL in adults visiting a dental hospital in Navi Mumbai

  2. To assess the role of dietary and oral hygiene habits in the development of NCCL in the study population

  3. To assess the role of salivary characteristics in development of NCCL in the study population

  4. To assess the role of abnormal occlusal forces in the development of NCCL in the study population

500 participants as per the following inclusion and exclusion criteria will be selected. For the purpose of the study, a special questionnaire was developed, similar to those used in previously conducted epidemiological studies. Either one of the two examiners will conduct the clinical examination. Examination process will be carried out in the dental chair with adequate lighting and the help of a mirror and Williams graduated probe for all the patients. Loupes with magnification of 3.2X (Admetec, Israel) will be used for clinical examination. Intra- and inter-examiner reliability will be checked with Cohen’s Kappa coefficient. Any food debris obscuring vision will be cleaned before assessment. Any non-carious loss of hard tissues at the cervix of the tooth, such as wedge-shaped, disc-shaped, flattened and irregular defects, will be identified through visual or tactile examination. For smaller lesions, differentiation will be based on comparison between the morphology of the same area observed on adjacent and contralateral teeth. Teeth with NCCLs will be graded according to Smith and Knight’s index. Lesions will be characterized according to their shape as rounded or concave, wedge shaped, and mixed. For assessing the flow rate of saliva, samples will be analyzed for a total of 58 patients. Samples will be taken from 29 patients of both genders,40,41 who will have been diagnosed with multiple NCCLs (>3) and 29 patients of both genders without any signs of cervical lesions and cervical restorations, who will represent the control group. One day before collecting samples, patients will be instructed not to eat, drink, smoke and brush their teeth for at least 60 minutes before arrival. The quantity of saliva will be investigated by measuring the flow rate of unstimulated and stimulated saliva. Qualitative analysis will be done by checking the saliva acidity coefficient (pH) of stimulated and unstimulated saliva by a pH meter in two groups of 29 patients each. The saliva buffering capacity of the saliva samples will be assessed by actively mixing 1 ml of saliva to 3 ml of 0.005% hydrochloric acid. The data obtained from the questionnaire and intraoral examinations will be subjected to descriptive analysis, bivariate analysis through Chi-square test, bivariate and multivariate regression models.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 89.00 Year(s)(—)
性别
All

入选标准

  • Subjects having a pure vegetarian, mixed or non-vegetarian dietary preference, Patients with or without medical conditions, those who consent to participate in the study, participants having a minimum of eight teeth, participants able to read and/or understand the questionnaire.

排除标准

  • Participants with diseases requiring mood-altering medications, participants who are unable to understand and respond to the questionnaire, participants with Teeth having cervical fillings, Patients who have undergone full mouth rehabilitation, Patients that are currently wearing fixed orthodontic appliances, Patients having teeth with erosive defects on the occlusal surfaces, and the occlusal two-thirds of the buccal and lingual surfaces.

结局指标

主要结局

Non-Carious Cervical Lesions

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Gaurav Kulkarni
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Gaurav Kulkarni

Terna Dental College and Hospital

研究点 (1)

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