Study of Growing Biofilm by an Antiplaque Mouthrinse (Bain de bouche)
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.
|Dental Plaque||Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) Other: mouthrinse containing non-active component||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|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 Dental Plaque Deposit in a 4-days Plaque Regrowth Model|
- 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 ]
- 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 ]
|Study Start Date:||February 2009|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate)
Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)
Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days
Placebo Comparator: 2
Antiplaque mouthrinse containing non-active component
Other: mouthrinse containing non-active component
Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838266
|CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet|
|Bordeaux, France, 33075|
|Principal Investigator:||Cécile BADET, MD||University Hospital, Bordeaux|