Powertoothbrushing for Treating Gingivitis

In this single-masked, parallel-armed, interventional clinical trial for treatment of
gingivitis we 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.

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