Study of Growing Biofilm by an Antiplaque Mouthrinse (Bain de bouche)
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)
mouthrinse containing non-active component
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque focused on measuring mouthrinse, grape seed extract, fluor, plaque index
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate)
Antiplaque mouthrinse containing non-active component
Outcomes
Primary Outcome Measures
Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining.
Secondary Outcome Measures
Product tolerance
Product acceptability (oral sensation)
Full Information
NCT ID
NCT00838266
First Posted
February 5, 2009
Last Updated
September 22, 2009
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT00838266
Brief Title
Study of Growing Biofilm by an Antiplaque Mouthrinse
Acronym
Bain de bouche
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
mouthrinse, grape seed extract, fluor, plaque index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Antiplaque mouthrinse containing non-active component
Intervention Type
Drug
Intervention Name(s)
mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)
Intervention Description
Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days
Intervention Type
Other
Intervention Name(s)
mouthrinse containing non-active component
Intervention Description
Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Product tolerance
Time Frame
on days 5 of the two plaque growth periods
Title
Product acceptability (oral sensation)
Time Frame
on days 5 of the two plaque growth periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile BADET, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet
City
Bordeaux
ZIP/Postal Code
33075
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
7558357
Citation
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.
Results Reference
background
PubMed Identifier
3517110
Citation
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.
Results Reference
background
PubMed Identifier
12622853
Citation
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.
Results Reference
background
PubMed Identifier
18795979
Citation
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.
Results Reference
background
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Study of Growing Biofilm by an Antiplaque Mouthrinse
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