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

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ClinicalTrials.gov Identifier: NCT00838266
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Dental Plaque Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) Other: mouthrinse containing non-active component Phase 3

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Product tolerance [ Time Frame: on days 5 of the two plaque growth periods ]
  2. Product acceptability (oral sensation) [ Time Frame: on days 5 of the two plaque growth periods ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838266


Locations
France
CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet
Bordeaux, France, 33075
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Cécile BADET, MD University Hospital, Bordeaux

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
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009

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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs