MedTrace Logo

Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

NCT04092075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-07-29

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

Conditions

  • Gingivitis
  • Plaque
  • Calculus, Dental

Interventions

DEVICE

RF-utilizing powered toothbrush

RF-utilizing Powered toothbrush

DEVICE

Control placebo with no RF

Placebo control, toothbrush with no RF

Sponsors & Collaborators

  • Home Skinovations Ltd.

    lead INDUSTRY

Principal Investigators

  • Bennett T Amaechi, BDS, MS, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2020-04-30
Completion
2020-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04092075 on ClinicalTrials.gov