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

Gingivitis Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Gingivitis
• Plaque

• NCT number: NCT04197427
• Study type: Interventional
• Source: You First Services
• Contact: Sebastian Ciancio, D.D.S
• Phone: 716-829-3848
• Email: ciancio@buffalo.ed
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Completion date: December 31, 2020