Dental Caries, Periodontal Disease
Conditions
Keywords
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.
Interventions
DRUG0.12 % chlorhexidine + 0.2 % NaF mouthrinse
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.
DRUG0.2 % NaF mouthrinse
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.
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.
OTHERPlacebo
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.
Sponsors
Göteborg University
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plaque index | Baseline |
| Gingivitis index | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Lactobacilli counts in dental plaque and saliva | Day 0 |
| Mutans streptococci counts in dental plaque and saliva | Day 0 |
| Total bacterial counts in dental plaque and saliva | Day 0 |
| Streptococcus sanguinis counts in dental plaque and saliva | Day 0 |
| Streptococcus sanguis counts in dental plaque and saliva | Day 42 |
Outcome results
None listed