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Clinical Trials/CTRI/2025/03/083569
CTRI/2025/03/083569
Not yet recruiting
Phase 4

Evaluation of three different oral hygiene aids among 12 to 15 years Autism spectrum disorder children in Madurai - A Randomized control trial

Best Dental College Madurai1 site in 1 country45 target enrollmentStarted: April 10, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Best Dental College Madurai
Enrollment
45
Locations
1
Primary Endpoint
Oral Hygiene Status using Oral hygiene simplified index, plaque index, gingival index.

Overview

Brief Summary

This study is a randomized parallel group trial comparing three different oral hygiene aids such as conventional toothbrush, Electric toothbrush and water flosser. Each group contains 15 Autism children. Brushing technique and oral health education is given to parents /caretakers and reinforced every month till the completion of the study. Baseline data collected using indices (such as plaque index, gingival index and oral hygiene index-simplified) and questionnaire to caretakers. Data collection using indices is done in 1st month , 3rd month and 6th month.Questionnaire is also collected during 6th month data collection. Questionnaire contains questions regarding attitude and practice of oral hygiene of autism children. From the datas collected we can come to a conclusion of which oral hygiene aid is better and we can extrapolate to all autism children.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
12.00 Year(s) to 15.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Both male and female Age group 12 to 15 MDPS A grade Consent from parents/guardians.

Exclusion Criteria

  • Under Antiepileptics Any systemic disease No willingness Chronic absentee.

Outcomes

Primary Outcomes

Oral Hygiene Status using Oral hygiene simplified index, plaque index, gingival index.

Time Frame: Baseline before using respective oral hygiene aid | 1 month after using respective oral hygiene aid | 3 months after using respective oral hygiene aid | 6months after using respective oral hygiene aid

Secondary Outcomes

  • Improvement in oral hygiene status(1 month after using respective oral hygiene aid)

Investigators

Sponsor
Best Dental College Madurai
Sponsor Class
Other [Private Dental College and Hospital]
Responsible Party
Principal Investigator
Principal Investigator

Dr. Kaarthikeyan P S

Best Dental Science college

Study Sites (1)

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