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Not yet recruiting NCT06554782

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

No phase Interventional Manual Toothbrush

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: manual u-shaped toothbrush.
Who it may be relevant to
Registry conditions: Manual Toothbrush. Basic parameters: 5 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • compliance of patient [Time frame: 1 week]
Secondary outcome measures (1)
  • full mouth plaque score [Time frame: 1 week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ashkenazi M, Bidoosi M, Levin L. Factors associated with reduced compliance of children to dental preventive measures. Odontology. 2012 Jul;100(2):241-8. doi: 10.1007/s10266-011-0034-1. Epub 2011 Jun 23. PMID 21698350
  • Davidovich E, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Zini A. Randomised clinical study of plaque removal efficacy of a power toothbrush in a paediatric population. Int J Paediatr Dent. 2017 Nov;27(6):558-567. doi: 10.1111/ipd.12298. Epub 2017 May 11. PMID 28494116

Identifiers

NCT: NCT06554782 · U-shaped toothbrush

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗