Powertoothbrushing for Treating Gingivitis

Marquette University55 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingivitis

Interventions

Oscillating rotating power toothbrushDEVICE

a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Marquette University School of Dentistry

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Change in Gingivitis

Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.

Time frame: 12 weeks post-baseline

Data from ClinicalTrials.gov

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