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CTRI Number  CTRI/2024/10/075263 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Gum-line Tooth Notching in Adult Patients Visiting a Dental Hospital in Navi Mumbai and Possible Risk Factors Associated with it 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Kulkarni 
Designation  PhD Scholar 
Affiliation  Terna Dental College and Hospital 
Address  Room no. 201. Department of Conservative Dentistry. Terna Dental College and Hospital. Sector 22. Nerul. Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9767234101  
Fax    
Email  drgauravkulkarni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sumanthini MV 
Designation  Prof. & HOD, PhD Guide 
Affiliation  Terna Dental College and Hospital 
Address  Dept. of Conservative Dentistry and Endodontics. MGM Dental College and Hospital. Sector 1. Kamothe. Navi Mumbai.
Dept. of Conservative Dentistry and Endodontics. Terna Dental College. Nerul. Navi Mumbai. Maharashtra. 400706
Thane
MAHARASHTRA
410209
India 
Phone    
Fax    
Email  margsuman@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Kulkarni 
Designation  PhD Scholar 
Affiliation  Terna Dental College and Hospital 
Address  Room no. 201. Department of Conservative Dentistry. Terna Dental College and Hospital. Sector 22. Nerul. Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9767234101  
Fax    
Email  drgauravkulkarni@gmail.com  
 
Source of Monetary or Material Support  
Terna Dental College and Hospital, Sector 22. Nerul West, Opposite Railway Station. Navi Mumbai. Maharashtra. India. 400706. 
 
Primary Sponsor  
Name  Gaurav Kulkarni 
Address  A 1402. 39 Anthea. Tilak Nagar. Chembur. Mumbai. Maharashtra. India. 400089 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Kulkarni  Terna Dental College and Hospital  Room no. 201. Department of Conservative Dentistry and Endodontics. 2nd Floor. Terna Dental College and Hospital. Nerul. Navi Mumbai
Thane
MAHARASHTRA 
9769234101

drgauravkulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Mahatma Gandhi Missions Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non carious cervical lesion 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Non-Carious Cervical Lesions  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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
4) To assess the role of salivary characteristics in development of NCCL in the study population
5) 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.
 
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