Interaction Between Chlorhexidine and Fluoride

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Periodontal Disease
• Intervention / Treatment: Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse; Drug: 0.2 % NaF mouthrinse; Drug: 0.12% chlorhexidine; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Göteborg University
• Investigators: Study Chair: Per Ramberg, Professor, Göteborg University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Prevention
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Periodontal Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Dnr 745-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided