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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 October 19, 2014