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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
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque focused on measuring mouthrinse, grape seed extract, fluor, plaque index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 5, 2009
Last Updated
September 22, 2009
Sponsor
University Hospital, Bordeaux
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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
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Study of Growing Biofilm by an Antiplaque Mouthrinse

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