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Clinical Trials/CTRI/2024/12/078458
CTRI/2024/12/078458
Not yet recruiting
Phase 2

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

Dr Srivardhini S1 site in 1 country140 target enrollmentStarted: January 30, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Dr Srivardhini S
Enrollment
140
Locations
1
Primary Endpoint
Effectiveness of a customized oral health program to improve the Oral Health Related

Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Gypsy/Narikuravars residing in Pondicherry and Cuddalore district.
  • Subjects who are willing to participate and those who give consent.

Exclusion Criteria

  • Subjects suffering from chronic debilitating conditions like Epilepsy etc.
  • and/or on long term medications which could influence their oral status.
  • Subjects with major neurological problems and congenital problems will be excluded.
  • Subjects who have psychiatric illness and mental retardation.

Outcomes

Primary Outcomes

Effectiveness of a customized oral health program to improve the Oral Health Related

Time Frame: 6 months

Quality of Life among gypsies

Time Frame: 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Srivardhini S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Srivardhini S

Indira Gandhi Institute of Dental Sciences

Study Sites (1)

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