NCT00838266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 2, 2026

Status Verified

September 1, 2009

Enrollment Period

28 days

First QC Date

February 5, 2009

Last Update Submit

May 29, 2026

Conditions

Dental Plaque

Keywords

mouthrinsegrape seed extractfluorplaque index

Outcome Measures

Primary Outcomes (1)

  • Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining.

    Measures are done on days 5 of the two plaque growth periods

Secondary Outcomes (2)

  • Product tolerance

    on days 5 of the two plaque growth periods

  • Product acceptability (oral sensation)

    on days 5 of the two plaque growth periods

Study Arms (2)

1

EXPERIMENTAL

Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate)

Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)

2

PLACEBO COMPARATOR

Antiplaque mouthrinse containing non-active component

Other: mouthrinse containing non-active component

Interventions

mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)DRUG

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

1
mouthrinse containing non-active componentOTHER

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Alcoholic consumption more than 20 g/day (or 2 glasses)
  • Heavy smokers
  • Volunteers drinking a lot of tea or coffee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bordeaux, 33075, France

Location

Related Publications (4)

  • 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.

    PMID: 7558357BACKGROUND

  • 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. doi: 10.1016/s0002-8177(86)24021-0. No abstract available.

    PMID: 3517110BACKGROUND

  • 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. doi: 10.1034/j.1600-051x.2003.00205.x.

    PMID: 12622853BACKGROUND

  • 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. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13.

    PMID: 18795979BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Officials

  • Cécile BADET, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 2, 2026

Record last verified: 2009-09

Locations

FR(1)