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Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis

NCT06126250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-11-13

No results posted yet for this study

Summary

The goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on supragingival dental plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.

Conditions

  • Plaque Induced Gingivitis

Interventions

DEVICE

Power sonic toothbrush

Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.

DEVICE

Manual toothbrush

Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.

Sponsors & Collaborators

  • Lander Enterprises, LLC

    lead INDUSTRY

Principal Investigators

  • Robert T. Nierman, DMD, MS · Timber Falls Dental Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2023-10-27
Completion
2023-10-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126250 on ClinicalTrials.gov