Interaction Between Chlorhexidine and Fluoride

Phase 4

Completed

• Conditions: Dental Caries; Periodontal Disease
• Interventions: Drug: 0.12% chlorhexidine; Other: Placebo; Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse; Drug: 0.2 % NaF mouthrinse

• Registration Number: NCT02935322
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0.12% chlorhexidine mouthrinse	0.12% chlorhexidine	A mouthrinse containing chlorhexidine
Placebo mouthrinse	Placebo	A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride
0.12 % chlorhexidine + 0.2 % NaF mouthrinse	0.12 % chlorhexidine + 0.2 % NaF mouthrinse	A mouthrinse combining chlorhexidine and NaF
0.2 % NaF mouthrinse	0.2 % NaF mouthrinse	A mouthrinse containing NaF

Primary Outcome Measures

Name	Time	Method
Plaque index	Day 42
Gingivitis index	Day 42

Secondary Outcome Measures

Name	Time	Method
Mutans streptococci 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 42
Streptococcus sanguis counts in dental plaque and saliva	Day 42
Total bacterial counts in dental plaque and saliva	Day 42