Powertoothbrushing for Treating Gingivitis

Marquette University

Status: Completed

Conditions: Gingivitis

Treatments: Device: Oscillating rotating power toothbrush

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03381339

MarquetteU

Details and patient eligibility

About

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.

Full 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

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Powered toothbrush intervention

Experimental group

Description:

Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.

Treatment:

Device: Oscillating rotating power toothbrush

Manual toothbrush

No Intervention group

Description:

Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.