ToothWave Calculus Reduction and Accumulation Prevention Study

Not Applicable

Completed

• Conditions: Plaque; Gingivitis; Calculus, Dental
• Interventions: Device: Control placebo with no RF; Device: RF-utilizing powered toothbrush

• Registration Number: NCT04596761
• Lead Sponsor: Home Skinovations Ltd.

Brief Summary

The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.

Detailed Description

This is a parallel group, single-blind, randomized, and controlled prospective study aimed to evaluate the safety and efficacy of the ToothWave in calculus reduction and prevention of calculus accumulation.

Eligible subjects will undergo a dental prophylaxis, and will enter a two-month run-in phase. A Volpe-Manhold Index (V-MI) calculus examination will be per-formed at the end of the run-in phase. A minimum of 90 qualified subjects (completers) who will form at least 9 mm of calculus on the lingual surface of the mandibular anterior teeth and will qualify to continue participation ac-cording to the eligibility criteria and will be randomly assigned to either the ToothWave or the control brush (ADA-accepted powered TB) group. Subjects will be stratified according to calculus levels (which indicates the calculus growth rate). Stratification will also be conducted according to age, gender, and ethnic group. Subjects will brush twice daily, unsupervised, during a three-month test period, returning at Weeks 3, 6 and 12 for safety and V-MI examinations. An additional visit will be conducted at week 9, during which a supervised brushing will be conducted.

The study test phase will include a total of 168 treatment sessions and 5 clinic visits over a period of 12 weeks.

For each subject, assessment data will be collected at baseline, and at 3, 6 and 12 weeks of the test phase. The average data sets will be calculated for each group.

Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the ToothWave and standard fluoride toothpaste. The control group will use a regular powered toothbrush and standard fluoride toothpaste.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-07-15
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control placebo with no RF	Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Treatment group	RF-utilizing powered toothbrush	The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush

Primary Outcome Measures

Name	Time	Method
Calculus	6-12 weeks	A significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
reduction of calculus compared to baseline	6-12 weeks	reduction in the treatment group as compared to baseline following 12 weeks of treatment
Oral health	12 weeks	Subjective impression by study participants in their oral health status in the treatment group following 12 weeks of treatment.
prevention of calculus accumulation	6-12 weeks	prevention of calculus accumulation in the treatment group as seen by no significant increase in calculus score as compared to baseline.

Trial Locations

Locations (1)

Salus Research; 🇺🇸 Fort Wayne, Indiana, United States