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

M

Mahidol University

Status

Completed

Conditions

Effectiveness of Toothbrush

Treatments

Device: Triple-headed toothbrush

Study type

Interventional

Funder types

Other

Identifiers

NCT07373249
MU-DT/PY-lRB 2024/ 060.2409

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

3 to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Developmental disability children aged 3 to 6 years old who have full primary dentition.
  • The caregivers who responsible for brushing their child's teeth that must be the same person throughout the study and able to attend both study sessions

Exclusion criteria

  • Developmental disability children who have periodontal disease, soft tissue ulcers or gingival abscess.
  • Developmental disability children who have missing tooth more than one tooth per sextant.
  • Developmental disability children who have definitely negative behavior (Frankl behavior rating scale one) (89) during oral examination
  • Parents of Developmental disability children who have a physical or mental disability which may influence to their brushing ability.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Triple and single headed toothbrush
Experimental group
Description:
Crossover study compared effectiveness of tripled and single headed toothbrush
Treatment:
Device: Triple-headed toothbrush

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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