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Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
Chlorhexidine
Chlorhexidine
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Chlorhexidine, Cetyl pyridinium chloride, Mouth rinse, Antiplaque Efficacy, Self Efficacy, Taste Sweet, Side Effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculdade de Medicina Dentária da Universidade do Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antiplaque Efficacy

Taste and Side Effects

Arm Description

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.

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?").

Outcomes

Primary Outcome Measures

antiplaque efficacy
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
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
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?"

Full Information

First Posted
April 16, 2012
Last Updated
April 20, 2012
Sponsor
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT01580943
Brief Title
Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base
Official Title
Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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®).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Chlorhexidine, Cetyl pyridinium chloride, Mouth rinse, Antiplaque Efficacy, Self Efficacy, Taste Sweet, Side Effects

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antiplaque Efficacy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Taste and Side Effects
Arm Type
Active Comparator
Arm Description
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?").
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
0,12% CHX with 0,05% CPC (Perioaid®), 0,2% CHX non-alcohol base (Corsodyl® Care)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
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?").
Primary Outcome Measure Information:
Title
antiplaque efficacy
Description
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).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
taste
Description
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.
Time Frame
72 hours
Title
Side Effects
Description
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?"
Time Frame
72h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Alves, DDS
Organizational Affiliation
Faculdade de Medicina Dentária da Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina Dentária da Universidade do Porto
City
Porto
ZIP/Postal Code
4200-393
Country
Portugal

12. IPD Sharing Statement

Links:
URL
http://www.fmd.up.pt
Description
Click here for more information about this study: Efficacy of two commercially available chlorhexidine mouthrinses non-alcohol base - a randomized clinical trial

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Efficacy of Two Commercially Available Chlorhexidine Mouthrinses Non-alcohol Base

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