Clinical trial NCT04596761: ToothWave Calculus Reduction and Accumulation Prevention Study
Official title: Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Plaque
Calculus, Dental
Lead sponsor: Home Skinovations Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind prospective study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Adult subjects aged 18 years and older, that are in good health.
2. Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
3. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
4. The subjects should be willing to comply with the study procedures and schedule, including the follow up visits.
5. Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.

Exclusion Criteria

1. Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
2. Regular users of a chlorhexidine mouthrinse.
3. Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
4. Current or history of oral cavity cancer or oropharyngeal cancer.
5. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
6. Pregnant or nursing by subject report.
7. Subjects that do not brush regularly.
8. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.

Primary outcomes:
measure: Calculus
timeFrame: 6-12 weeks
Secondary outcomes:
measure: reduction of calculus compared to baseline
timeFrame: 6-12 weeks
measure: Oral health
timeFrame: 12 weeks
measure: prevention of calculus accumulation
timeFrame: 6-12 weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
affiliation: Salus Research
name: Jeffery L Milleman, DDS, MPA
role: PRINCIPAL_INVESTIGATOR
References: