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

September 22, 2009 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measures are done on days 5 of the two plaque growth periods

Secondary Outcome Measures

Outcome Measure
Time Frame
Product tolerance
Time Frame: on days 5 of the two plaque growth periods
on days 5 of the two plaque growth periods
Product acceptability (oral sensation)
Time Frame: on days 5 of the two plaque growth periods
on days 5 of the two plaque growth periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Cécile BADET, MD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2008/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Plaque

Clinical Trials on mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe