Study of Growing Biofilm by an Antiplaque Mouthrinse (Bain de bouche)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Plaque |
Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) Other: mouthrinse containing non-active component |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- Product tolerance [ Time Frame: on days 5 of the two plaque growth periods ] [ Designated as safety issue: Yes ]
- Product acceptability (oral sensation) [ Time Frame: on days 5 of the two plaque growth periods ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteer
- without caries
- with at least 20 natural teeth excluding third molars
- Women using contraceptives for at least twelve weeks and while on study
- Protected by French social security system
- Written informed consent
Exclusion Criteria:
- Pregnancy or breast feeding
- Volunteers with partial denture or orthodontic appliance
- Person protected by the law who
- Person unable to give their consent to participate to the study.
- Under aged
- Current participation in another clinical trial
- Oral pathologies
- Systemic diseases
- Volunteers allergic to of the componentst of the tested products
- Volunteers with hyposalivation or xerostomia
- Treatment with antibiotics o intestinal antiseptics within 3 month before inclusion
- Treatment with oral antiseptics within 1 month before inclusion
- Alcoholic consumption more than 20 g/day (or 2 glasses)
- Heavy smokers
- Volunteers drinking a lot of tea or coffee
Contacts and Locations| France | |
| CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet | |
| Bordeaux, France, 33075 | |
| Principal Investigator: | Cécile BADET, MD | University Hospital, Bordeaux |
More Information
Publications:
| Responsible Party: | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00838266 History of Changes |
| Other Study ID Numbers: | CHUBX 2008/05 |
| Study First Received: | February 5, 2009 |
| Last Updated: | September 22, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Bordeaux:
|
mouthrinse grape seed extract fluor plaque index |
Additional relevant MeSH terms:
|
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Grape Seed Extract Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013