| 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
|
|
|
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
|
|
|
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. |