Clinical trial NCT02935322: Interaction Between Chlorhexidine and Fluoride
Official title: Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Dental Caries
Keywords: Prevention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2016-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Plaque index
timeFrame: Baseline
measure: Plaque index
timeFrame: Day 4
measure: Plaque index
timeFrame: Day 42
measure: Gingivitis index
timeFrame: Baseline
measure: Gingivitis index
timeFrame: Day 42
Secondary outcomes:
measure: Mutans streptococci counts in dental plaque and saliva
timeFrame: Day 0
measure: Mutans streptococci counts in dental plaque and saliva
timeFrame: Day 4
measure: Streptococcus sanguis counts in dental plaque and saliva
timeFrame: Day 42
measure: Lactobacilli counts in dental plaque and saliva
timeFrame: Day 0
measure: Lactobacilli counts in dental plaque and saliva
timeFrame: Day 4
measure: Lactobacilli counts in dental plaque and saliva
timeFrame: Day 42
measure: Streptococcus sanguinis counts in dental plaque and saliva
timeFrame: Day 0
measure: Streptococcus sanguinis counts in dental plaque and saliva
timeFrame: Day 4
measure: Streptococcus sanguinis counts in dental plaque and saliva
timeFrame: Day 42
measure: Total bacterial counts in dental plaque and saliva
timeFrame: Day 0
measure: Total bacterial counts in dental plaque and saliva
timeFrame: Day 4
measure: Total bacterial counts in dental plaque and saliva
timeFrame: Day 42
Other outcomes:
Locations:
Study officials:
affiliation: Göteborg University
name: Per Ramberg, Professor
role: STUDY_CHAIR
References:
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.
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.
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.
citation: Dahlen G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42.
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.