Study of Growing Biofilm by an Antiplaque Mouthrinse

NCT ID: NCT00838266

Last Updated: 2009-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: EXPERIMENTAL

mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)

Intervention Type: DRUG

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

2

Antiplaque mouthrinse containing non-active component

Group Type: PLACEBO_COMPARATOR

mouthrinse containing non-active component

Intervention Type: OTHER

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

Interventions

mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)

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

Intervention Type: DRUG

mouthrinse containing non-active component

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Bordeaux

Principal Investigators

Cécile BADET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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

Bordeaux, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 7558357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3517110 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12622853 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18795979 (View on PubMed)

Other Identifiers

CHUBX 2008/05

Identifier Type: -

Identifier Source: org_study_id