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

Not Applicable

Completed

• Conditions: Plaque Removal
• Interventions: Other: old toothbrush; Other: New tooth brush

• Registration Number: NCT00836784
• Lead Sponsor: Shahid Beheshti University

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-04
• Last Update Posted: 2009-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Exclusion Criteria

1. subjects who wearing oral prosthesis,orthodontic brackets or removable appliances
2. subjects using mouthwashes which improve the oral hygiene

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	old toothbrush	-
2	New tooth brush	-

Primary Outcome Measures

Name	Time	Method
Turesky plaque index	before and after brushing the teeth

Trial Locations

Locations (1)

Shahid Beheshti University; 🇮🇷 Tehran, Iran, Islamic Republic of