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

February 10, 2025 updated by: Rana Sobhy Saeed, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manual u-shaped toothbrush
manual u-shaped toothbrush with arm angled 45 degrees to brush upper and lower arch at the same time
Device: manual u-shaped toothbrush
manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time
Experimental: manual toothbrush
manual toothbrush with soft bristles and circular movement to clean each quadrant separately
Device: manual u-shaped toothbrush
manual u-shaped toothbrush with bristles angled 45 degrees to brush upper and lower teeth at the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compliance of patient
Time Frame: 1 week
questioning the parents about compliance either yes or no
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
full mouth plaque score
Time Frame: 1 week
Turesky modified Quigley-Hein plaque index technique index score: total score/number of surfaces examined 0-1= low >2= high
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: randa youssef abdelgawad, professor, Cairo University
  • Study Director: Rana Tarek Bartaw, assistant professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • U-shaped toothbrush

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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