NCT07373249

The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability

The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability: A Randomized Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The Objectives 1. To evaluate the efficacy of dental plaque removal between triple-headed and single-headed toothbrushes in preschool children with developmental disabilities through parental brushing 2. To assess the parental satisfaction with triple-headed toothbrushes

Detailed description

This study was a single-blind, randomized crossover study. 24 Parents of children with developmental disabilities (DD) were invited to participate in the study. Baseline data including demographic information, plaque index, and dmft, were collected. Participants were randomly assigned to receive their first toothbrush, either a single-head toothbrush (Berman®; soft and flat bristles for preschool children) or a triple-head toothbrush (Dr. Barman's Superbrush®; soft and flat bristles, size 0-6 years). Parents received toothbrushing instruction via a video clip according to the randomly assigned sequence of toothbrush type. Parents were then allowed to perform toothbrushing for their children. The quality of toothbrushing performance for each sextant was evaluated by the examiner using a toothbrushing performance form. Overall toothbrushing time was also recorded. All participants were advised to use their own toothbrush during the washout period. After a four-week washout period, participants crossed over to the alternate toothbrush type, and all procedures were repeated. At the end of the study, parents completed a satisfaction questionnaire regarding the triple-headed toothbrush.

Conditions

• Effectiveness of Toothbrush

Interventions

Type	Name	Description
DEVICE	Triple-headed toothbrush	The triple-headed toothbrush has been introduced to enhance brushing effectiveness as a design of three sides bristles, with each head capable of cleaning the buccal, lingual, and occlusal surfaces simultaneously. It is particularly suitable for individuals with limited manual skills, such as those with physical and mental handicaps, young or preschool children, especially important for caregivers when patient cooperation during brushing is limited.The round-end design is beneficial for easier brushing, reducing time, and improving cleaning efficiency, as proven in numerous studies

Timeline

• Start date: 2025-06-17
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Thailand