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Completed

NCT Number: NCT00838266

Study of Growing Biofilm by an Antiplaque Mouthrinse

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet

Bordeaux, 33075, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)

Drug

Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days

mouthrinse containing non-active component

Other

Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: Bain de bouche

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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