Comparison of New and 3-Month-Old Toothbrush in the Removal of Plaque in Children
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.
|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.|
- Turesky plaque index [ Time Frame: before and after brushing the teeth ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836784
|Iran, Islamic Republic of|
|Shahid Beheshti University|
|Tehran, Iran, Islamic Republic of|
|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|