Interaction Between Chlorhexidine and Fluoride
Primary Purpose
Periodontal Disease, Dental Caries
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.12 % chlorhexidine + 0.2 % NaF mouthrinse
0.2 % NaF mouthrinse
0.12% chlorhexidine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Periodontal Disease focused on measuring Prevention
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects, age 18-35 years
- Good general health
- No signs of periodontitis and caries
- A minimum of 24 teeth with no extensive restorations
- No current or planned dental treatment during the trial periods.
Exclusion Criteria:
- Antibiotic treatment within 1 month prior to the start of the trial
- Current medication with anti-inflammatory drugs
- Use of antiseptic mouthrinses
- Smokers and snuff user
- Use of chewing gums
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
0.12 % chlorhexidine + 0.2 % NaF mouthrinse
0.2 % NaF mouthrinse
0.12% chlorhexidine mouthrinse
Placebo mouthrinse
Arm Description
A mouthrinse combining chlorhexidine and NaF
A mouthrinse containing NaF
A mouthrinse containing chlorhexidine
A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride
Outcomes
Primary Outcome Measures
Plaque index
Plaque index
Plaque index
Gingivitis index
Gingivitis index
Secondary Outcome Measures
Mutans streptococci counts in dental plaque and saliva
Mutans streptococci counts in dental plaque and saliva
Streptococcus sanguis counts in dental plaque and saliva
Lactobacilli counts in dental plaque and saliva
Lactobacilli counts in dental plaque and saliva
Lactobacilli counts in dental plaque and saliva
Streptococcus sanguinis counts in dental plaque and saliva
Streptococcus sanguinis counts in dental plaque and saliva
Streptococcus sanguinis counts in dental plaque and saliva
Total bacterial counts in dental plaque and saliva
Total bacterial counts in dental plaque and saliva
Total bacterial counts in dental plaque and saliva
Full Information
NCT ID
NCT02935322
First Posted
October 10, 2016
Last Updated
October 12, 2016
Sponsor
University of Oslo
Collaborators
Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT02935322
Brief Title
Interaction Between Chlorhexidine and Fluoride
Official Title
Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study was to study if there are interactions and reduced clinical effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.
Detailed Description
The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week period of brushing. Two studies were designed as double-blind, randomized, cross-over clinical trials. In study I, 16 healthy subjects rinsed twice daily for 1 min during 4 days of no tooth brushing with four mouthrinse solutions: 1) 0.12% CHX + 0.2% NaF, 2) 0.2% NaF, 3) 0.12% CHX, and 4) placebo. In study 2, 16 healthy subjects rinsed with the same four solutions twice daily after tooth brushing during a 6-week period. Primary outcomes were plaque formation and gingivitis. Secondary outcomes were fluoride retention and microbiological parameters in plaque and saliva (total bacterial counts and mutans streptococci, lactobacilli and streptococci sanguinis counts). One way analyses of variance with post hoc Student-Newman-Keul´s statistical test was performed for comparisons between mouthrinses. Intragroup changes over time were analyzed with a paired t-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Dental Caries
Keywords
Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.12 % chlorhexidine + 0.2 % NaF mouthrinse
Arm Type
Active Comparator
Arm Description
A mouthrinse combining chlorhexidine and NaF
Arm Title
0.2 % NaF mouthrinse
Arm Type
Active Comparator
Arm Description
A mouthrinse containing NaF
Arm Title
0.12% chlorhexidine mouthrinse
Arm Type
Active Comparator
Arm Description
A mouthrinse containing chlorhexidine
Arm Title
Placebo mouthrinse
Arm Type
Placebo Comparator
Arm Description
A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride
Intervention Type
Drug
Intervention Name(s)
0.12 % chlorhexidine + 0.2 % NaF mouthrinse
Other Intervention Name(s)
Chlorhexidine + NaF mouthwash
Intervention Description
In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.
Intervention Type
Drug
Intervention Name(s)
0.2 % NaF mouthrinse
Other Intervention Name(s)
NaF mouthwash
Intervention Description
In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.
Intervention Type
Drug
Intervention Name(s)
0.12% chlorhexidine
Other Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Contained all basic ingredients as the other three mouthrinses but no chlorhexidine and no NaF. In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
In study II, subjects were asked to rinse with 10ml of the assigned solution twice daily after tooth brushing during a 6-week period.
Primary Outcome Measure Information:
Title
Plaque index
Time Frame
Baseline
Title
Plaque index
Time Frame
Day 4
Title
Plaque index
Time Frame
Day 42
Title
Gingivitis index
Time Frame
Baseline
Title
Gingivitis index
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Mutans streptococci counts in dental plaque and saliva
Time Frame
Day 0
Title
Mutans streptococci counts in dental plaque and saliva
Time Frame
Day 4
Title
Streptococcus sanguis counts in dental plaque and saliva
Time Frame
Day 42
Title
Lactobacilli counts in dental plaque and saliva
Time Frame
Day 0
Title
Lactobacilli counts in dental plaque and saliva
Time Frame
Day 4
Title
Lactobacilli counts in dental plaque and saliva
Time Frame
Day 42
Title
Streptococcus sanguinis counts in dental plaque and saliva
Time Frame
Day 0
Title
Streptococcus sanguinis counts in dental plaque and saliva
Time Frame
Day 4
Title
Streptococcus sanguinis counts in dental plaque and saliva
Time Frame
Day 42
Title
Total bacterial counts in dental plaque and saliva
Time Frame
Day 0
Title
Total bacterial counts in dental plaque and saliva
Time Frame
Day 4
Title
Total bacterial counts in dental plaque and saliva
Time Frame
Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects, age 18-35 years
Good general health
No signs of periodontitis and caries
A minimum of 24 teeth with no extensive restorations
No current or planned dental treatment during the trial periods.
Exclusion Criteria:
Antibiotic treatment within 1 month prior to the start of the trial
Current medication with anti-inflammatory drugs
Use of antiseptic mouthrinses
Smokers and snuff user
Use of chewing gums
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ramberg, Professor
Organizational Affiliation
Göteborg University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
4532119
Citation
Axelsson P, Lindhe J. The effect of a preventive programme on dental plaque, gingivitis and caries in schoolchildren. Results after one and two years. J Clin Periodontol. 1974;1(2):126-38. doi: 10.1111/j.1600-051x.1974.tb01248.x. No abstract available.
Results Reference
background
PubMed Identifier
3422503
Citation
Barkvoll P, Rolla G, Bellagamba S. Interaction between chlorhexidine digluconate and sodium monofluorophosphate in vitro. Scand J Dent Res. 1988 Feb;96(1):30-3. doi: 10.1111/j.1600-0722.1988.tb01404.x.
Results Reference
background
PubMed Identifier
266752
Citation
Emilson CG. Susceptibility of various microorganisms to chlorhexidine. Scand J Dent Res. 1977 May;85(4):255-65. doi: 10.1111/j.1600-0722.1977.tb00561.x.
Results Reference
background
PubMed Identifier
6585909
Citation
Dahlen G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42.
Results Reference
background
PubMed Identifier
292158
Citation
Dolles OK, Bonesvoll P, Gamst ON, Gjermo P. Determination of fluoride and chlorhexidine from chlorhexidine/fluoride-containing dentifrices. Scand J Dent Res. 1979 Apr;87(2):115-22. doi: 10.1111/j.1600-0722.1979.tb00662.x.
Results Reference
background
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Interaction Between Chlorhexidine and Fluoride
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