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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06554782
Enrollment
47
Registered
2024-08-15
Start date
2025-04-30
Completion date
2026-01-31
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Manual Toothbrush

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.

Interventions

DEVICEmanual u-shaped toothbrush

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
compliance of patient1 weekquestioning the parents about compliance either yes or no

Secondary

MeasureTime frameDescription
full mouth plaque score1 weekTuresky modified Quigley-Hein plaque index technique index score: total score/number of surfaces examined 0-1= low \>2= high

Contacts

Primary ContactRana Sobhy Saeed, bachelor
ranaelagamy@gmail.com01156633838
Backup ContactOmar Mohammed Ellithy, bachelor
omar.eleathy@gmail.com01119868815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026