At-Home Care for Subjects With Periodontitis

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-08-10

Brief Summary

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The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).

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Detailed Description

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Conditions

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Periodontitis Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ADA (American Dental Association) approved Manual Toothbrush

Group Type ACTIVE_COMPARATOR

ADA approved Manual Toothbrush

Intervention Type DEVICE

ADA approved Manual Toothbrush

Marketed Power Toothbrush

Group Type EXPERIMENTAL

Marketed Power Toothbrush

Intervention Type DEVICE

Marketed Power Toothbrush

Interventions

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ADA approved Manual Toothbrush

Intervention Type DEVICE

Marketed Power Toothbrush

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 18-75 years
* Exhibiting Stage I or II periodontitis
* Minimum of 20 'scorable' teeth (excluding 3rd molars)
* Regular manual toothbrush user
* Have a minimum average plaque score of \> 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
* Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period
* Be a non-smoker (\> 10 years), or never smoker

Exclusion Criteria

* Have a cardiac pacemaker or implanted cardiac defibrillator
* Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
* Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
* Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
* Have had a professional prophylaxis within 4 weeks of the study
* Prior chemotherapy, immunotherapy or radiation therapy within last 10 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes