Interaction Between Chlorhexidine and Fluoride

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study

Conditions
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Periodontal Disease, Dental Caries

Intervention / Treatment
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* Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse
* Drug: 0.2 % NaF mouthrinse
* Drug: 0.12% chlorhexidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse<br>A mouthrinse combining chlorhexidine and NaF | Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse<br>* 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.<br>* Other names: Chlorhexidine + NaF mouthwash;|
| Active Comparator: 0.2 % NaF mouthrinse<br>A mouthrinse containing NaF | Drug: 0.2 % NaF mouthrinse<br>* 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.<br>* Other names: NaF mouthwash;|
| Active Comparator: 0.12% chlorhexidine mouthrinse<br>A mouthrinse containing chlorhexidine | Drug: 0.12% chlorhexidine<br>* 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.<br>* Other names: Chlorhexidine mouthwash;|
| Placebo Comparator: Placebo mouthrinse<br>A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index |  | Baseline | 
| Plaque index |  | Day 4 | 
| Plaque index |  | Day 42 | 
| Gingivitis index |  | Baseline | 
| Gingivitis index |  | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutans streptococci counts in dental plaque and saliva |  | Day 0 | 
| Mutans streptococci counts in dental plaque and saliva |  | Day 4 | 
| Streptococcus sanguis counts in dental plaque and saliva |  | Day 42 | 
| Lactobacilli counts in dental plaque and saliva |  | Day 0 | 
| Lactobacilli counts in dental plaque and saliva |  | Day 4 | 
| Lactobacilli counts in dental plaque and saliva |  | Day 42 | 
| Streptococcus sanguinis counts in dental plaque and saliva |  | Day 0 | 
| Streptococcus sanguinis counts in dental plaque and saliva |  | Day 4 | 
| Streptococcus sanguinis counts in dental plaque and saliva |  | Day 42 | 
| Total bacterial counts in dental plaque and saliva |  | Day 0 | 
| Total bacterial counts in dental plaque and saliva |  | Day 4 | 
| Total bacterial counts in dental plaque and saliva |  | Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention