Interaction Between Chlorhexidine and Fluoride

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935322
• Other study ID #: Dnr 745-11
• 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

Related Conditions & MeSH terms

• Dental Caries
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

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