Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Toothbrush

Not Applicable

Not yet recruiting

• Conditions: Manual Toothbrush
• Interventions: Device: manual u-shaped toothbrush

• Registration Number: NCT06554782
• Lead Sponsor: Cairo University

Brief Summary

To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.

Detailed Description

Research has shown that an undesirably high proportion of communities find thorough toothbrushing with a standard manual toothbrush challenging to achieve a plaque-free state, as evidenced by high worldwide gingivitis and periodontitis. This is consistent with investigations that reveal insufficient frequency of brushing, poor brushing technique, and inadequate brushing session duration when compared with standard-of-care professional recommendations.

The U-shaped brush is an intervention chosen for the present study because it can attract children's attention and make brushing fun and routine. With bristles angled at 45° and available in various sizes according to age, the U-shaped brush is useful for removing plaque. It can be used starting at age three or older. It is dependable for children because its two-sided design can clean the upper and lower arches in one motion. Since design affects plaque removal to varying degrees, various authors have examined the effects of different toothbrush designs on plaque removal.

Study Timeline

• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Start: 2025-04
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. children aged 5 to 10 years, in good general health, and medically free.
2. Cooperative patients who will comply with follow-ups.
3. Parents who accept to sign informed consent.

Exclusion Criteria

1. Children with fixed or removable orthodontic appliances.
2. Children with a physical disability, and medical disability.
3. Children who will be unable to attend follow-up visits.
4. Parents refuse to give written formed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual toothbrush	manual u-shaped toothbrush	manual toothbrush with soft bristles and circular movement to clean each quadrant separately
manual u-shaped toothbrush	manual u-shaped toothbrush	manual u-shaped toothbrush with arm angled 45 degrees to brush upper and lower arch at the same time

Primary Outcome Measures

Name	Time	Method
compliance of patient	1 week	questioning the parents about compliance either yes or no

Secondary Outcome Measures

Name	Time	Method
full mouth plaque score	1 week	Turesky modified Quigley-Hein plaque index technique index score: total score/number of surfaces examined 0-1= low \>2= high