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NCT Number: NCT06554782

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

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

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Key information

Conditions

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

manual u-shaped toothbrush

Device

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

Primary outcomes

  1. compliance of patient

    Time frame: 1 week

    questioning the parents about compliance either yes or no

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Mohammed Ellithy, bachelor

CONTACT

[email protected]

01119868815

Rana Sobhy Saeed, bachelor

CONTACT

[email protected]

01156633838

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.