Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children
Completed · Not applicable · Has a placebo group
Conditions studied: Dental Plaque
In brief
The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.
Key facts
- Study ID
- NCT06300073
- Run by
- Lander Enterprises, LLC
- People needed
- 22
- Starts
- 2023-02-14
- Expected to finish
- 2023-02-17
- Last updated by the study team
- 2024-03-08
Who can join
Age: 5 and older, up to 8. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Subjects presenting with any of the following will not be included in the study:
- Having a history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Having self-reported serious medical conditions.
- Being under treatment for a heart condition requiring use of a pacemaker.
- Having anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Having had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
- Having participated in any study involving oral care products, concurrently or within the 30 days of screening exams.
- Presence of severe periodontal disease or being actively treated for periodontal disease.
- Having grossly carious, fully crowned, or extensively restored teeth.
- Having orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Having significant oral soft tissue pathology based on a visual examination.
Where it is running
- Salus Research, Inc — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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