NCT04197427

Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: You First Services · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath

Detailed description

This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)

Conditions

• Plaque
• Gingivitis

Interventions

Type	Name	Description
DEVICE	Experimental Oral Rinse	Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
DEVICE	Placebo	Placebo formulation without the active ingredients

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-11-30
• Completion: 2020-12-31
• First posted: 2019-12-13
• Last updated: 2019-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study