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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935322
Other study ID # Dnr 745-11
Secondary ID
Status Completed
Phase Phase 4
First received October 10, 2016
Last updated October 12, 2016
Start date September 2009
Est. completion date February 2012

Study information

Verified date October 2016
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Sweden: Central Ethical Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
0.12 % 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.
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.
0.12% chlorhexidine
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.
Other:
Placebo
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Oslo Göteborg University

References & Publications (5)

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. — View Citation

Barkvoll P, Rölla G, Bellagamba S. Interaction between chlorhexidine digluconate and sodium monofluorophosphate in vitro. Scand J Dent Res. 1988 Feb;96(1):30-3. — View Citation

Dahlén G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42. — View 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. — View Citation

Emilson CG. Susceptibility of various microorganisms to chlorhexidine. Scand J Dent Res. 1977 May;85(4):255-65. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque index Baseline No
Primary Plaque index Day 4 No
Primary Plaque index Day 42 No
Primary Gingivitis index Baseline No
Primary Gingivitis index Day 42 No
Secondary Mutans streptococci counts in dental plaque and saliva Day 0 No
Secondary Mutans streptococci counts in dental plaque and saliva Day 4 No
Secondary Streptococcus sanguis counts in dental plaque and saliva Day 42 No
Secondary Lactobacilli counts in dental plaque and saliva Day 0 No
Secondary Lactobacilli counts in dental plaque and saliva Day 4 No
Secondary Lactobacilli counts in dental plaque and saliva Day 42 No
Secondary Streptococcus sanguinis counts in dental plaque and saliva Day 0 No
Secondary Streptococcus sanguinis counts in dental plaque and saliva Day 4 No
Secondary Streptococcus sanguinis counts in dental plaque and saliva Day 42 No
Secondary Total bacterial counts in dental plaque and saliva Day 0 No
Secondary Total bacterial counts in dental plaque and saliva Day 4 No
Secondary Total bacterial counts in dental plaque and saliva Day 42 No
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