Efficacy of New Alcohol Free Mouthrinses
Primary Purpose
Gum Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
alcohol-free experimental mouth rinse
alcohol-containing mouth rinsing
Sponsored by
About this trial
This is an interventional supportive care trial for Gum Disease
Eligibility Criteria
Inclusion Criteria:
- participants between 18 and 65 years
- no severe periodontitis
- informed consent
Exclusion Criteria:
- handicapped participants
- allergies against mouth rinses
Sites / Locations
- Witten/Herdecke University School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
No Intervention
Arm Label
toothbrushing plus rinsing
alcohol-free experimental mouth rinse
toothbrushing and rinsing
toothbrushing alone
Arm Description
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
0.06% CHX + 0.025% NaF plus toothbrushing
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
negative control
Outcomes
Primary Outcome Measures
Modified Proximal Plaque Index (MPPI)
Secondary Outcome Measures
Full Information
NCT ID
NCT01811615
First Posted
January 18, 2013
Last Updated
March 13, 2013
Sponsor
University of Witten/Herdecke
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01811615
Brief Title
Efficacy of New Alcohol Free Mouthrinses
Official Title
A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.
Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gum Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
toothbrushing plus rinsing
Arm Type
Active Comparator
Arm Description
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
Arm Title
alcohol-free experimental mouth rinse
Arm Type
Experimental
Arm Description
0.06% CHX + 0.025% NaF plus toothbrushing
Arm Title
toothbrushing and rinsing
Arm Type
Experimental
Arm Description
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
Arm Title
toothbrushing alone
Arm Type
No Intervention
Arm Description
negative control
Intervention Type
Other
Intervention Name(s)
alcohol-free experimental mouth rinse
Intervention Type
Other
Intervention Name(s)
alcohol-containing mouth rinsing
Primary Outcome Measure Information:
Title
Modified Proximal Plaque Index (MPPI)
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
participants between 18 and 65 years
no severe periodontitis
informed consent
Exclusion Criteria:
handicapped participants
allergies against mouth rinses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zimmer, Professor
Organizational Affiliation
Witten/Herdecke University
Official's Role
Study Director
Facility Information:
Facility Name
Witten/Herdecke University School of Dental Medicine
City
Witten
State/Province
NRW
ZIP/Postal Code
58455
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy of New Alcohol Free Mouthrinses
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