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Study of Growing Biofilm by an Antiplaque Mouthrinse (Bain de bouche)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00838266
First received: February 5, 2009
Last updated: September 22, 2009
Last verified: September 2009

February 5, 2009
September 22, 2009
February 2009
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00838266 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Growing Biofilm by an Antiplaque Mouthrinse
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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Plaque
  • Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)
    Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days
  • Other: mouthrinse containing non-active component
    Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
  • Experimental: 1
    Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate)
    Intervention: Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)
  • Placebo Comparator: 2
    Antiplaque mouthrinse containing non-active component
    Intervention: Other: mouthrinse containing non-active component

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00838266
CHUBX 2008/05
No
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Cécile BADET, MD University Hospital, Bordeaux
University Hospital, Bordeaux
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP