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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT00836784
First received: February 3, 2009
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Plaque Removal
 Other: old toothbrush
Other: New tooth brush

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparing Efficacy of Old Versus New Toothbrushes in Plaque Removal in the Hands of 7-9 Year Old Children.

Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • Turesky plaque index [ Time Frame: before and after brushing the teeth ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: 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.
Other Name: worn toothbrush
Experimental: 2 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.
Other Name: unused toothbrush

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.

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836784

Locations
Iran, Islamic Republic of
Shahid Beheshti University
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
Study Chair: Beheshte Malekafzali Shahid Beheshti medical Science University
Study Director: Mina Biria Shahid Beheshti medical Science University
Principal Investigator: Hoshyar Abbasi Shahid Beheshti Medical Science University
  More Information

No publications provided

Responsible Party: Beheshte Malekafzali, Shahid beheshti medical University
ClinicalTrials.gov Identifier: NCT00836784     History of Changes
Other Study ID Numbers: 123456
Study First Received: February 3, 2009
Last Updated: May 4, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti University:
Old tooth brush
Plaque removal

ClinicalTrials.gov processed this record on June 18, 2013