Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base
Information source: Universidade do Porto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Plaque
Intervention: Chlorhexidine (Drug); Chlorhexidine (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Universidade do Porto Official(s) and/or principal investigator(s): Daniel Alves, DDS, Principal Investigator, Affiliation: Faculdade de Medicina Dentária da Universidade do Porto
Summary
The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine
and 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine
non-alcohol base mouth rinse (Corsodyl Care®).
Clinical Details
Official title: Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base - a Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: antiplaque efficacy
Secondary outcome: tasteSide Effects
Detailed description:
Dental plaque is a bacterial biofilm adhering to the tooth surfaces and is not the same in
the different areas of the tooth: there is the supragingival, the plaque from the gingival
margin and subgingival plaque. It is mainly composed of complex bacterial populations
organized in a carbohydrate matrix also containing a small number of epithelial cells,
leukocytes, macrophages and inorganic components such as calcium and phosphorus. This
biofilm develops in virtually all places where there are damp surfaces and teeth are a very
stable support for bacterial colonization. Mechanical oral hygiene procedures such as tooth
brushing, dental flossing and inter-dental brushing is the most effective method for plaque
removal but mouth rinses containing anti-microbials play an important role in maintaining
oral health.
Chlorhexidine (CHX) digluconate, a cationic biguanide, is known to be an effective
anti-plaque and anti-inflammatory agent and is the gold standard in chemical plaque control.
The benefits of CHX are based on the high intra-oral substantivity and its bactericidal and
bacteriostatic activities. This ingredient, when delivered orally, is free from systemic
toxicity and microbial resistance, and supra-infections do not occur. It has been proven in
several "in vitro" and "in vivo" studies, the safety and long-term efficacy of CHX mouth
rinses. There have been suggested many indications for the use of this antiseptic and plaque
control is one of the most important factors for proper healing after periodontal surgery
and implant therapy.
The 0. 2% CHX solution became the standard international concentration, due to his
development in Europe but similar levels of plaque inhibition can be achieved with larger
volumes of lower concentration solutions of CHX.
A lower concentration of CHX (0. 12%) has been tested in several studies and has also been
shown to confer clinical benefits. More important than the concentration of CHX seems to be
the dose which balances efficacy against local side effects and user acceptability. The
optimum dose is considered to be about 20 mg twice daily.
Clinically, the 0,12% CHX have been found to be similarly effective as 0. 2% if the volume of
the rinse was increased from 10 to 15 ml, yielding an 18 mg dose on each occasion but with
respect to plaque growth inhibition, there is a small but significant difference in favour
of the 0. 2% CHX concentration.
CHX mouthrinses can have a variety of side effects and the most common, according to the
manufacturers of these products, are loss of taste, tongue burning and irritation of the
oral mucosa. Some brands have lowered the concentration of CHX in their mouthrinses and
removed the ethanol in order to eliminate side effects such as soreness and to improve
acceptability. A study concluded that the perturbation of taste perception after using
0. 12% CHX is significantly lower than that after using 0. 2% CHX. On the other hand, another
studies concluded that there was no significant difference in terms of taste perception.
This study was a double-blinded, randomized two group parallel, to compare the antiplaque
efficacy of two mouth rinses, during a 3-day plaque accumulation model, in periodontal
healthy patients. After supragingival prophylaxis participants rinsed twice a day over a 72h
non-brushing period. Primary outcome variable was plaque index. As secondary outcomes the
taste and side effects variables were studied. Mann-Whitney, χ2 and Fisher's Exact tests
were used to compare the variables
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Good general health without a medical history or medication that might interfere with
the conduct of the study
- Dentition with at least 24 teeth (minimum of five teeth per quadrant)
- Periodontal health, pockets < 5mm
Exclusion Criteria:
- Pregnant women or in lactation
- Participants with orthodontic or removable dental appliances
- Known allergies to CHX, CPC or to another ingredient of the mouth rinses
- Systemic antibiotic intake in the previous 3 months
Locations and Contacts
Faculdade de Medicina Dentária da Universidade do Porto, Porto 4200-393, Portugal
Additional Information
Click here for more information about this study: Efficacy of two commercially available chlorhexidine mouthrinses non-alcohol base - a randomized clinical trial
Starting date: October 2011
Last updated: April 20, 2012
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