Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush

Church & Dwight

Status

Completed

Conditions

Plaque, Dental

Treatments

Device: Battery operated toothbrush

Device: Manual toothbrush

Study type

Interventional

Funder types

Industry

Identifiers

NCT04794452

ST-20-U82

Details and patient eligibility

About

To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

Full description

This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.

After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.

Enrollment

60 patients

Sex

All

Ages

5 to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

5 to 8 years
Be a regular manual toothbrush user.

Exclusion criteria

Have any physical limitations or restrictions which might preclude normal tooth brushing.
Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
Have fixed or removable orthodontic appliances.