Safety and Efficacy of the ToothWave - Calculus Study

University of Texas Health Science Center
18 Nov, 2019 ,

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.

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This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.

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.

Study Type: Interventional  (Clinical Trial)

Estimated Enrollment: 90 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description:Single-blind prospective study

Masking: Single (Outcomes Assessor)

Masking Description: The Outcomes Assessors will not be exposed to the type of brush the subject is using or to the group they are assigned to (treatment or control).

Primary Purpose: Treatment

Official Title: Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.

Actual Study Start Date: August 7, 2019

Estimated Primary Completion Date: May 31, 2020

Estimated Study Completion Date: May 31, 2020

Primary Outcome Measures  :

  1. Calculus [ Time Frame: 12 weeks ]

    A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.

Secondary Outcome Measures  :

  1. Dental plaque [ Time Frame: 6 weeks ]

    A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.

  2. Gingival inflammation [ Time Frame: 6 weeks ]

    A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).

Ages Eligible for Study:  18 Years to 70 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  Yes

Criteria

Inclusion Criteria

  1. Adult subjects aged 18-70, that are in good health.
  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

  1. Current or history of oral cavity cancer or oropharyngeal cancer.
  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.