N/A
N=55
Powertoothbrushing for Treating Gingivitis
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT03381339 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Gingivitis — 0.14; 0.19 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oscillating rotating power toothbrush (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marquette University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gingivitis |
0.14; 0.19 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A subject who meets all the following criteria will be eligible to enroll in this study.
- Age range 18 - 65 years
- Routine manual toothbrush user
- 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.
- 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.
- Probing Pocket Depth (PPD) of 4 mm or lower
- 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.
- Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device
- Regular user of antimicrobial mouthrinses within one week of entry into study
- Professional prophylaxis within one month of entry into the study
- Use of antibiotics within one month prior to the baseline exam
- Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher
- Subjects with orthodontic bands and/or dental appliances.
- Participated in an oral care related study in the last 90 days prior to this study
- Pregnant or lactating women
- Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study
- Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc.
- History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders
- Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day)
- Current Smoker (within the last 3 months)
- Other medical or dental conditions that would affect the study
- Inability to commit to all necessary study visits from baseline to 12 weeks
Data sourced from ClinicalTrials.gov (NCT03381339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.