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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Manual Toothbrush

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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manual u-shaped toothbrush

manual u-shaped toothbrush with arm angled 45 degrees to brush upper and lower arch at the same time

Group Type EXPERIMENTAL

manual u-shaped toothbrush

Intervention Type DEVICE

manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time

manual toothbrush

manual toothbrush with soft bristles and circular movement to clean each quadrant separately

Group Type EXPERIMENTAL

manual u-shaped toothbrush

Intervention Type DEVICE

manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time

Interventions

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manual u-shaped toothbrush

manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes