| CTRI Number |
CTRI/2024/12/078458 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Oral Health and Quality of Life in Gypsy Communities of Pondicherry and Cuddalore Through a Customized Oral Health Program A Quasi Experimental Study
|
|
Scientific Title of Study
|
Effectiveness of a customized oral health program to improve the Oral Health Related
Quality of Life among gypsies in Pondicherry and Cuddalore district – A quasi experimental
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 |
Dr Srivardhini S |
| Designation |
Postgraduate 2nd Year |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, 7th floor, Indira Gandhi Institute of Dental Sciences SBV Pondicherry campus pillayarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9500819986 |
| Fax |
|
| Email |
srivardhinimnc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil M |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, 7th floor, Indira Gandhi Institute of Dental Sciences SBV Pondicherry campus pillayarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9486365954 |
| Fax |
|
| Email |
senthilm@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil M |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, 7th floor, Indira Gandhi Institute of Dental Sciences SBV Pondicherry campus pillayarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9486365954 |
| Fax |
|
| Email |
senthilm@igids.ac.in |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Sciences SBV Pondicherry campus Pillayarkuppam Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Dr Srivardhini S |
| Address |
Indira Gandhi Institute of Dental Sciences SBV Pondicherry campus Pillayarkuppam Pondicherry 607402 |
| 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 Srivardhini S |
Indira Gandhi Institute of Dental Sciences SBV University |
7th floor, Department of Public Health Dentistry
Pondicherry
PONDICHERRY |
9500819986
srivardhinimnc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Indira Gandhi Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Oral Health Education and Comprehensive treatment program |
Study participants will receive a toothbrush and toothpaste, along with education on proper oral hygiene practices, including using a pea-sized amount of toothpaste and the modified Bass toothbrushing technique demonstrated on models. They will also learn about other aids like tongue cleaners, flossing, and rinsing after meals. Instructions will cover toothbrush storage, replacement every three months, regular oral prophylaxis (every 6–12 months), and addressing oral health misconceptions. Awareness about tobacco-related habits will be included. A standardized oral health education program will be developed for the gypsy population. Participants will undergo dental screening, followed by necessary treatments such as scaling, restorations, and extractions.
Duration of the intervention is 1 week.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Gypsy/Narikuravars residing in Pondicherry and Cuddalore district. Subjects who are willing to participate and those who give consent. |
|
| ExclusionCriteria |
| Details |
Subjects suffering from chronic debilitating conditions like Epilepsy etc. and/or on long term medications which could influence their oral status. Subjects with history of receiving antibiotic and/or antiseptic therapy. Subjects with major neurological problems and congenital problems will be excluded. Subjects who have psychiatric illness and mental retardation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of a customized oral health program to improve the Oral Health Related
Quality of Life among gypsies |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of a customized oral health program on Debris score and calculus scores among gypsies |
6 months |
| Effectiveness of a customized oral health program on Dentition status and periodontal status among gypsies |
6 months |
| Effectiveness of a customized oral health program on tobacco and tobacco related habits among gypsies |
6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
AIM: To assess the effectiveness of a customized oral health program to improve the Oral Health Related Quality of Life among Gypsy/Narikuravars. RESEARCH QUESTION: Is there a difference in the Oral Health Related Quality of Life among gypsies before and after giving a customized oral health program? STUDY POPULATION: Narikuravars/Gypsy aged between 18-60 years population. SAMPLING PROCEDURE: The sampling method by which the study subjects would be selected is Cluster Sampling. SAMPLE SIZE: The sample size was calculated using G power software version 3.1. The calculation was based on the mean DMFT values (5.30 ± 3.160) among narikuravars from a previous study conducted by Mahalakshmi kumaraguru et al (2023). With 95% power and alpha error 5%, the sample size was calculated to be 132. Anticipating a 10% loss to follow up, the sample size is calculated as 140. Thus, the total sample size N=140. METHODOLOGY: The study subjects will be selected using cluster sampling based on the inclusion criteria and exclusion criteria. At baseline, demographic data , Oral Health Related Quality of Life using Oral Health Impact Profile (OHIP 14) questionnaire and GATS questionnaire will be collected by interview method. Debris score and calculus score will be assessed using Oral Hygiene Index – Simplified by Greene & Vermillion in 1964. To assess the dentition status, periodontal status and loss of attachment using WHO oral health assessment form for adults, 2013. INTERVENTION: Study participants will receive a toothbrush and toothpaste, along with education on proper oral hygiene practices, including using a pea-sized amount of toothpaste and the modified Bass toothbrushing technique demonstrated on models. They will also learn about other aids like tongue cleaners, flossing, and rinsing after meals. Instructions will cover toothbrush storage, replacement every three months, regular oral prophylaxis (every 6–12 months), and addressing oral health misconceptions. Awareness about tobacco-related habits will be included. A standardized oral health education program will be developed for the gypsy population. Participants will undergo dental screening, followed by necessary treatments such as scaling, restorations, and extractions. 1 – month visit: Subjects will be clinically evaluated with Oral Hygiene Index – Simplified and WHO 2013 form. Oral health education will be reinforced. 3 – month visit: Subjects will be clinically evaluated with Oral Hygiene Index – Simplified and WHO 2013 form. Oral health education will be reinforced. 6 – month visit : Subjects will be clinically evaluated by Oral Hygiene Index – Simplified, WHO 2013 form, GATS questionnaire and Oral Health Impact Profile (OHIP 14) questionnaire will be collected by interview method. Oral health education will be reinforced |