Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Sá Alves, Universidade do Porto
ClinicalTrials.gov Identifier:
NCT01580943
First received: April 16, 2012
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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®).


Condition Intervention Phase
Dental Plaque
Drug: Chlorhexidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base - a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade do Porto:

Primary Outcome Measures:
  • antiplaque efficacy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

    antiplaque efficacy of two chlorhexidine mouth rinses: 0,12% chlorhexidine with 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) and a 0,2% chlorhexidine alcohol free mouth rinse (Corsodyl Care®) At baseline, all participants received a through supragingival dental prophylaxis to remove all stain, calculus and plaque.

    After 72h all participants were disclosed with a 1% erythrosine solution and the plaque in both groups was recorded at six sites per tooth on a 5-point scale using the Quigley & Hein (1962) plaque index as modified by Turesky et al. (1970).



Secondary Outcome Measures:
  • taste [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    All subjects received a questionnaire using a visual analogue scale designed to evaluate their taste to the mouthrinse, which they had used (What is your opinion concerning the taste of the mouth rinse?). Subjects marked a point on a 10 cm long uncalibrated line with the negative extreme response (0) on the left and the positive extreme (10) at the right end.

  • Side Effects [ Time Frame: 72h ] [ Designated as safety issue: No ]
    The participants were asked about side effects in an open answer: "Did you feel any side effects caused by mouth rinse?", "If so, what were they?"


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antiplaque Efficacy

This study was designed as a randomized, two group parallel, double-blind, 3-day non-brushing clinical trial. The sample size (50 participants) was determined using similar studies, making it a convenience sample.

Over a 72-h experimental non-brushing period, subjects abstained from all forms of mechanical oral hygiene and one group (test) used an 0.12% CHX mouthrinse with 0.05% CPC (Perioaid®), twice daily for 30 seconds and the other group (positive control) used a 0.2% CHX mouthrinse alcohol free (Corsodyl® Care), twice daily for 60 seconds.

Drug: Chlorhexidine
Over a 72-h experimental non-brushing period, subjects abstained from all forms of mechanical oral hygiene and one group (test) used an 0.12% CHX mouthrinse with 0.05% CPC (Perioaid®), twice daily for 30 seconds and the other group (positive control) used a 0.2% CHX mouthrinse alcohol free (Corsodyl® Care), twice daily for 60 seconds. These regimens are suggested by the manufacturers in the instructions
Other Names:
  • 0,12% CHX with 0,05% CPC (Perioaid®)
  • 0,2% CHX non-alcohol base (Corsodyl® Care)
Active Comparator: Taste and Side Effects
All subjects received a questionnaire using a visual analogue scale designed to evaluate their taste to the mouthrinse, which they had used (What is your opinion concerning the taste of the mouth rinse?). Subjects marked a point on a 10 cm long uncalibrated line with the negative extreme response (0) on the left and the positive extreme (10) at the right end. Then, they were also asked about side effects in an open answer ("Did you feel any side effects caused by mouth rinse?", "If so, what are they?").
Drug: Chlorhexidine
All subjects received a questionnaire using a visual analogue scale designed to evaluate their taste to the mouthrinse, which they had used (What is your opinion concerning the taste of the mouth rinse?). Subjects marked a point on a 10 cm long uncalibrated line with the negative extreme response (0) on the left and the positive extreme (10) at the right end. Then, they were also asked about side effects in an open answer ("Did you feel any side effects caused by mouth rinse?", "If so, what are they?").

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580943

Locations
Portugal
Faculdade de Medicina Dentária da Universidade do Porto
Porto, Portugal, 4200-393
Sponsors and Collaborators
Universidade do Porto
Investigators
Principal Investigator: Daniel Alves, DDS Faculdade de Medicina Dentária da Universidade do Porto
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Sá Alves, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier: NCT01580943     History of Changes
Other Study ID Numbers: FMDUP101351003
Study First Received: April 16, 2012
Last Updated: April 20, 2012
Health Authority: Portugal: School of Dental Medicine, University of Porto, Porto, Portugal

Keywords provided by Universidade do Porto:
Chlorhexidine
Cetyl pyridinium chloride
Mouth rinse
Antiplaque Efficacy
Self Efficacy
Taste Sweet
Side Effects

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Stomatognathic Diseases
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014