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Completed

NCT Number: NCT00836784

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.

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Key information

Conditions

Plaque Removal

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Beheshti University

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

old toothbrush

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.

Other names: worn toothbrush

New tooth brush

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.

Other names: unused toothbrush

Primary outcomes

  1. Turesky plaque index

    Time frame: before and after brushing the teeth

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 4, 2009
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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