Dental PlaquePhase 3Bain de boucheNCT00838266
Study of Growing Biofilm by an Antiplaque Mouthrinse
A Phase 3 study testing mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) and mouthrinse containing non-active component in people with Dental Plaque, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) and mouthrinse containing non-active component
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet
Bordeaux, 33075
About this study
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
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.
Read the 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
- Conditions
- Dental Plaque
- Being tested
- mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate), mouthrinse containing non-active component
- Keywords
- mouthrinse, grape seed extract, fluor, plaque index
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 componentOther
Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate) Receives: Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) |
| 2 | Placebo comparator | Antiplaque mouthrinse containing non-active component Receives: Other: mouthrinse containing non-active component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining.
Measured: Measures are done on days 5 of the two plaque growth periods
Secondary outcomes (2)
Product tolerance
Measured: on days 5 of the two plaque growth periods
Product acceptability (oral sensation)
Measured: on days 5 of the two plaque growth periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile BADET, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838266
- Sponsor's protocol ID
- CHUBX 2008/05
- Other IDs
- 2008-A00575-50
- Acronym
- Bain de bouche
- Status last verified
- Sep 2009
- First submitted
- 5 Feb 2009
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 7558357Guidelines 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.
PubMed 3517110Yates 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.
PubMed 12622853Furiga 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.
PubMed 18795979
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00838266
- Acronym / sponsor ID
- Bain de bouche / CHUBX 2008/05
- Conditions
- Dental Plaque
- Keywords
- mouthrinse, grape seed extract, fluor, plaque index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate) |
| 2 | Placebo comparator | Other: mouthrinse containing non-active componentAntiplaque mouthrinse containing non-active component |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days | Drug | 1 |
| mouthrinse containing non-active componentAntiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days | Other | 2 |
Primary outcome
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
2 secondary outcomes
Product tolerance
Time frame: on days 5 of the two plaque growth periods
Product acceptability (oral sensation)
Time frame: on days 5 of the two plaque growth periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 7558357Addy 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.
- Background: PubMed 3517110Guidelines 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.
- Background: PubMed 12622853Yates 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.
- Background: PubMed 18795979Furiga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile BADET, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) and mouthrinse containing non-active component in people with Dental Plaque, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838266, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.