Clinical Trial: Study of Growing Biofilm by an Antiplaque Mouthrinse
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary:
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
Sponsor: University Hospital, Bordeaux
Current Primary Outcome: Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining. [ Time Frame: Measures are done on days 5 of the two plaque growth periods ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Product tolerance [ Time Frame: on days 5 of the two plaque growth periods ]
- Product acceptability (oral sensation) [ Time Frame: on days 5 of the two plaque growth periods ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Bordeaux
Dates:
Date Received: February 5, 2009
Date Started: February 2009
Date Completion:
Last Updated: September 22, 2009
Last Verified: September 2009
