U Shaped Toothbrush in Removing Plaque in Children

Not Applicable

Active, not recruiting

• Conditions: Dental Plaque
• Interventions: Other: U shaped toothbrush group; Other: Traditional toothbrush group

• Registration Number: NCT06288581
• Lead Sponsor: Damascus University

Brief Summary

The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.

Children accepted in the study will be randomly divided into two groups:

The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)

Detailed Description

This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:

Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-03-01
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.

Exclusion Criteria

Children with limited ability to communicate. Children with motor disabilities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
U shaped toothbrush group	U shaped toothbrush group	children in this group will use a U-shaped brush first to clean their teeth then will use traditional brush later
Traditional toothbrush group	Traditional toothbrush group	Children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Primary Outcome Measures

Name	Time	Method
Changing in plaque index	Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush	0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic