Evaluation of the Effectiveness of Different Toothbrushes in Children
NCT ID: NCT06164496
Last Updated: 2023-12-21
Study Results
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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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-20
2024-01-20
Brief Summary
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Study design: Experimental study
Detailed Description
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Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p \< 0.05 was considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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control group
A control group will be formed using a manual brush with a classic head.
standart manual toothbrush
Device on plaque removal efficacy
study group
A study group will be formed using a 360-degree bristle brush.
360 degree toothbrush
Device on plaque removal efficacy
Interventions
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standart manual toothbrush
Device on plaque removal efficacy
360 degree toothbrush
Device on plaque removal efficacy
Eligibility Criteria
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Inclusion Criteria
* Children without systemic disease or developmental dental anomalies.
* Children not undergoing orthodontic treatment.
* Children with no decay on the labial surfaces of upper anterior incisors.
* Patients or their parents accepting participation in the treatment.
Exclusion Criteria
* Children undergoing orthodontic treatment.
* Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.
2 Years
5 Years
ALL
Yes
Sponsors
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Marmara University
OTHER
Responsible Party
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Locations
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Marmara University
Maltepe, Istanbul, Turkey (Türkiye)
Countries
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Facility Contacts
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Başak Durmuş, Prof.
Role: primary
Other Identifiers
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27.11.2023
Identifier Type: -
Identifier Source: org_study_id