Study of Growing Biofilm by an Antiplaque Mouthrinse - Full Text View

Sponsor:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00838266

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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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. Review.

[No authors listed] 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. No abstract available.

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.

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. Epub 2008 Sep 13.

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 - French Health Products Safety Agency

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 May 23, 2012