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OpenTrials
Completed

NCT Number: NCT04254770

At-Home Care for Subjects With Periodontitis

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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Key information

Conditions

Periodontitis Dental Deposits Dental Plaque Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADA approved Manual Toothbrush

Device

ADA approved Manual Toothbrush

Marketed Power Toothbrush

Device

Marketed Power Toothbrush

Primary outcomes

  1. Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.

    Time frame: 6 months

Secondary outcomes

  1. Change in supragingival plaque, as measured by Modified Plaque Index

    Time frame: 6 months

  2. Change in clinical attachment level

    Time frame: 6 months

  3. Change in periodontitis, as measured by probing pocket depth

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

A Randomized, Parallel-design Study to Evaluate the Effects of Home Use of the Sonicare Powered Toothbrush and a Manual Toothbrush on Subjects With Periodontitis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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