NCT03381339

Powertoothbrushing for Treating Gingivitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Marquette University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Gingivitis

Interventions

Type	Name	Description
DEVICE	Oscillating rotating power toothbrush	a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2017-12-22
• Last updated: 2021-04-05
• Results posted: 2021-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study