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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-04-30

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.

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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.

Conditions

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Plaque Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

old toothbrush

Intervention Type OTHER

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.

2

Group Type EXPERIMENTAL

New tooth brush

Intervention Type OTHER

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.

Interventions

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old toothbrush

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.

Intervention Type OTHER

New tooth brush

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.

Intervention Type OTHER

Other Intervention Names

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worn toothbrush unused toothbrush

Eligibility Criteria

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Inclusion Criteria

1. subjects should be have central and lateral incisors, first permanent molar in each quadrant of maxilla and mandible
2. they should be without restoration on facial, lingual surfaces
3. subjects should be healthy without any disabilities