Powertoothbrushing for Treating Gingivitis

Completed · Not applicable

Conditions studied: Gingivitis

In brief

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.

Key facts

Study ID

NCT03381339

Run by

Marquette University

People needed

55

Starts

2017-12-05

Expected to finish

2019-06-25

Last updated by the study team

2021-04-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Marquette University School of Dentistry — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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