NCT00838266

Study of Growing Biofilm by an Antiplaque Mouthrinse

A Double Blind Randomized, Placebo-controlled, Cross-over Trial to Evaluate the Efficiency of a Mouthrinse, Containing Red Grape Seed Extract and nicométhanol Fluorhydrate, in the Control of Dental Plaque Deposit in a 4-days Plaque Regrowth Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits. The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

Detailed description

The prevention of oral diseases is mainly targeted at the control of dental plaque. While tooth brushing is an effective method to remove plaque mechanically, it is not always sufficient and chemical antiplaque agents could be helpful. Some of them are used for their antibacterial action, the gold standard being chlorhexidine. Despite the great benefit of this bactericidal approach, the search continues for active ingredients that could prevent dental plaque formation without affecting the biological equilibrium within the oral cavity. The aim of this study is to evaluate the efficiency of a mouthrinse, containing red grape seed extract and nicométhanol fluorhydrate, in the control of dental plaque deposit in a 4-days plaque regrowth model. The study is a double blind randomized cross-over design, involving 50 healthy volunteers. During the treatment periods (4 days) no oral hygiene, measures excepting rinsing with the allocated product (active/non active) are permitted. On day 1, the subjects receive professional prophylaxis. The mouthrinse is used pure, three times per day, after each meal. On day 5, subjects will be scored for disclosed plaque using the Quigley Hein index (modified by Turesky). After a 2 weeks wash-out period, the subject receives the other product (active/non active) and uses it as in the first period. On day 5, subjects will be scored again for disclosed plaque

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DRUG	mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)	Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days
OTHER	mouthrinse containing non-active component	Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-06
• Last updated: 2009-09-23

Locations

1 site across 1 country: France