Effectiveness of various mechanical oral hygiene aids(like toothbrush,fingerbrush) among toddlers(2 to 3 yrs old children) in Chennai-A Randomized Controlled Trial

Completed

• Conditions: Chronic gingivitis,

• Registration Number: CTRI/2022/02/040616
• Lead Sponsor: SARANYASRI S

Brief Summary

The role of the accumulation of dental plaque in the development of dental caries and periodontal diseases is well established. Dental plaque is considered as one of the risk factor for caries in infants, toddlers and preschool children, mainly early childhood caries (ECC).So Toothbrushing should start as soon as the first teeth erupts into oral cavity. Various tooth cleaning aids like Toothbrushes of small sizes, finger toothbrush ,tooth and gum wipes are commercially available for the mothers to brush their child’s teeth.The aim of the present study is to evaluate the effectiveness of tooth wipes, gauze cloth,finger brush and manual toothbrush in removing dental plaque among the toddlers visiting various Play Schools and Child Day Care Centres in Chennai employing Randomized Controlled trial design.The sample comprising of toddlers aged 24 months to 36 months based on inclusion and exclusion criteria will be recruited from various Play Schools and Child Day Care Centresin Chennai by Multistage random sampling. Sample size is determined to be 36 in each groupusing the effect size calculated from previous study, Effectiveness of Tooth Wipes in Removing Babies’ Dental Biofilm by Abanto et al in 2012. Prior to recruitment, information regarding the study will be given to parents of the children and written informed consent will be obtained. Based on inclusion and exclusion criteria a total of 144 participants will berecruited to the randomised controlled trial. Prior to intervention the chief investigator will assess the baseline plaque score (Turesky -Gilmore-Glickman Modified Quigley-Hein Plaque Index (TQHPI) using disclosing agent) for all participants. All teeth will be assessed and the plaque revealed on the buccal and lingual surfaces of the teeth are given scores on a scale of 0 to 5, An index for the entire mouth is determined by dividing the total score by the number of surfaces examined.After baseline plaque score recording, the randomisation of the study participants to the 4 different intervention groups (TB (tooth brush group), FB (finger brush group), GC (gauze clothe group), and TW (tooth wipes group) will be done by providing Sequentially numbered, opaque, sealed envelope (SNOSE) technique by the co-investigator and the chief investigator is blinded to the intervention group the participants are allocated. The co-investigator provides the parent with the necessary oral hygiene aids viz. tooth brush or finger brush or gauze cloth or tooth wipes. Oral hygiene instructions regarding how to use the mechanical oral hygiene aids is explained to the parents using preformed, pretestedaudio-visual aid. The study participants are reviewed after 14 days and post intervention plaque score is recorded by the chief investigator. Compliance, ease of use and parents’ opinion regarding the usage of the mechanical aid will be obtained using a pretested, customised questionnaire.The data management and data analysis will be done using SPSS software version 21. Paired t test will be used to test the effectiveness of individual mechanical plaque control aid. ANOVA test will be used to compare the difference in effectiveness of the mechanical plaque control aids followed by post-hoc test

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-02
• Study Start: 2022-10-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Toddlers of age 24 to 36 months with normal developmental milestones.
• Have at least four incisors and 1st primary molar erupted.
• Toddlers scoring two to five in the Diet questions (Question no:13) of “WHO Oral Health Questionnaire for Children†(2013).

Exclusion Criteria

• Toddlers with 1.
• Systemic illness 2.
• Developmental anomalies 3.
• Rampant carieS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque score using Turesky -Gilmore-Glickman Modified Quigley-Hein Plaque	14TH DAY
Index (TQHPI)	14TH DAY

Secondary Outcome Measures

Name	Time	Method
compliance and acceptance of using oral hygiene aid	14th day

Trial Locations

Locations (1)

THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL; 🇮🇳 Chennai, TAMIL NADU, India

THE TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL

🇮🇳Chennai, TAMIL NADU, India

DR SARANYASRI S

Principal investigator

9791509571

drssaranyasri@gmail.com