Comparison of New and 3-Month-Old Toothbrush in the Removal of Plaque in Children

Study Overview
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Brief Summary
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This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted in 93 Iranian students aged between 7-9 year old.

Detailed Description
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At baselines, each student is given a new toothbrush which they will use for 3 months. The amount of wearing the 3-month-old brushes will determine by measurement of brushing surface areas using NIH imaging software. The outcomes will be measured after 3 month. The tooth brush which used in this study is Jordan with the following specifications: Length: 128 mm, 9 rows of bristles, 27 tufts, 24 monofilaments per tuft, height of monofilaments 10 mm and diameter of filaments 0.3 mm. The students will attend on two occasions following 48 hour periods of no oral hygiene. Following plaque scoring, students will brush with a new tooth brush at one visit and with a brush that they had used previously for 3 months at the other visit. Brushing time was 60 seconds. Plaque then will be re-scored and the percentage reduction in plaque score will be calculate using the Turesky plaque index. All plaque scoring will be performed by one examiner who is blind with the groups allocations.

Official Title
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Comparing Efficacy of Old Versus New Toothbrushes in Plaque Removal in the Hands of 7-9 Year Old Children.

Conditions
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Plaque Removal

Intervention / Treatment
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* Other: old toothbrush
* Other: New tooth brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects should be have central and lateral incisors, first permanent molar in each quadrant of maxilla and mandible they should be without restoration on facial, lingual surfaces subjects should be healthy without any disabilities Exclusion Criteria: subjects who wearing oral prosthesis,orthodontic brackets or removable appliances subjects using mouthwashes which improve the oral hygiene

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: old toothbrush<br>* All children will receive new tooth brush 3 months before starting the study, at the end of 3 month the worn tooth brushes will be returned and the surface area within the outline will be determine using NIH (national institutes of health) image software.<br>* Other names: worn toothbrush;|
| Experimental: 2<br> | Other: New tooth brush<br>* The tooth brush which will be use in this study is Jordan. A new Jordan toothbrush will be give to all children, and in new tooth brush group they will use these toothbrushes.<br>* Other names: unused toothbrush;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turesky plaque index |  | before and after brushing the teeth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Old tooth brush, Plaque removal