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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A00575-50 | Other Identifier | ANSM |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate) |
|
| 2 | Placebo Comparator | Antiplaque mouthrinse containing non-active component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) | Drug | Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining. | Measures are done on days 5 of the two plaque growth periods |
| Measure | Description | Time Frame |
|---|---|---|
| Product tolerance | on days 5 of the two plaque growth periods | |
| Product acceptability (oral sensation) | on days 5 of the two plaque growth periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile BADET, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet | Bordeaux | 33075 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7558357 | Background | Addy M. Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures. Int Dent J. 1995 Jun;45(3):185-96. | |
| 3517110 | Background | Guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. Council on Dental Therapeutics. J Am Dent Assoc. 1986 Apr;112(4):529-32. doi: 10.1016/s0002-8177(86)24021-0. No abstract available. |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| mouthrinse containing non-active component | Other | Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days |
|
| 12622853 | Background | Yates RJ, Shearer BH, Morgan R, Addy M. A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes. J Clin Periodontol. 2003 Feb;30(2):119-24. doi: 10.1034/j.1600-051x.2003.00205.x. |
| 18795979 | Background | Furiga A, Lonvaud-Funel A, Dorignac G, Badet C. In vitro anti-bacterial and anti-adherence effects of natural polyphenolic compounds on oral bacteria. J Appl Microbiol. 2008 Nov;105(5):1470-6. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13. |
| D004364 |
| Pharmaceutical Preparations |