Clinical trial NCT03381339: Powertoothbrushing for Treating Gingivitis
Official title: Powertoothbrushing for Treating Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: power toothbrush, oscillating rotating
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Sunstar, Inc.
First posted: 2017-12-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 month home use parallel-arm design to assess the efficacy of powered toothbrush use in the treatment of gingivitis in a moderate sized population, n=70.
Primary purpose: TREATMENT

Brief summary: In this three-month interventional clinical trial for the treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.

Detailed description: In this single-masked, parallel-armed, interventional clinical trial for treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene. The primary outcome variable is the change from baseline in the Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables include change from baseline in bleeding on probing as well as change from baseline in the Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation. There will also be an assessment of single use efficacy in reduction of overnight plaque levels at the baseline visit t

Eligibility criteria: Inclusion Criteria:

* A subject who meets all the following criteria will be eligible to enroll in this study.

  1. Age range 18 - 65 years
  2. Routine manual toothbrush user
  3. A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing.
  4. Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites.
  5. Probing Pocket Depth (PPD) of 4 mm or lower
  6. At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable).

Exclusion Criteria:

* Any subject meeting one of the following criteria will not be included in the study.

  1. Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device
  2. Regular user of antimicrobial mouthrinses within one week of entry into study
  3. Professional prophylaxis within one month of entry into the study
  4. Use of antibiotics within one month prior to the baseline exam
  5. Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher
  6. Subjects with orthodontic bands and/or dental appliances.
  7. Participated in an oral care related study in the last 90 days prior to this study
  8. Pregnant or lactating women
  9. Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study
  10. Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc.
  11. History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders
  12. Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day)
  13. Current Smoker (within the last 3 months)
  14. Other medical or dental conditions that would affect the study
  15. Inability to commit to all necessary study visits from baseline to 12 weeks

Primary outcomes:
measure: Change in Gingivitis
timeFrame: 12 weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University School of Dentistry
state: Wisconsin
Study officials:
References: