Evaluation of the Effectiveness of Different Toothbrushes in Children

Study Overview
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Brief Summary
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Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared. Study design: Experimental study

Detailed Description
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In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush. 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.

Official Title
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Evaluating the Effectiveness of Different Toothbrushes in Children

Conditions
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Dental Plaque, Plaque, Dental, Oral Hygiene, Gingivitis, Periodontal Indexes

Intervention / Treatment
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* Device: standart manual toothbrush
* Device: 360 degree toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children aged 2-12. 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 with decay on the labial surfaces of upper anterior incisors. Children undergoing orthodontic treatment. Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single blinded randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>A control group will be formed using a manual brush with a classic head. | Device: standart manual toothbrush<br>* Device on plaque removal efficacy<br>|
| Experimental: study group<br>A study group will be formed using a 360-degree bristle brush. | Device: 360 degree toothbrush<br>* Device on plaque removal efficacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal | Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured. | 2 weeks |