Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 6:58 AM
Study NCT ID:
NCT04596761
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ToothWave Calculus Reduction and Accumulation Prevention Study
Sponsor:
Home Skinovations Ltd.
Organization:
Study Overview
Official Title:
Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: