Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
NCT ID: NCT04092075
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2019-08-07
2020-04-30
Brief Summary
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Detailed Description
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The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks.
One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.
For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. 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 Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush
RF-utilizing powered toothbrush
RF-utilizing Powered toothbrush
Control group
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Control placebo with no RF
Placebo control, toothbrush with no RF
Interventions
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RF-utilizing powered toothbrush
RF-utilizing Powered toothbrush
Control placebo with no RF
Placebo control, toothbrush with no RF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must have:
2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).
2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.
3. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
4. 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.
5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
Exclusion Criteria
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing by subject report.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
6. Subjects that do not brush regularly.
7. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
18 Years
70 Years
ALL
Yes
Sponsors
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Home Skinovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bennett T Amaechi, BDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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DO116551A
Identifier Type: -
Identifier Source: org_study_id
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