Interaction Between Chlorhexidine and Fluoride

University of Oslo

Status and phase: Completed; Phase 4

Conditions: Dental Caries; Periodontal Disease

Treatments: Other: Placebo; Drug: 0.12% chlorhexidine; Drug: 0.2 % NaF mouthrinse; Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse

Study type: Interventional

Funder types: Other

Identifiers

NCT02935322

Dnr 745-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

Active Comparator group

Description:

A mouthrinse combining chlorhexidine and NaF

Treatment:

Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse

0.2 % NaF mouthrinse

Active Comparator group

Description:

A mouthrinse containing NaF

Treatment:

Drug: 0.2 % NaF mouthrinse

0.12% chlorhexidine mouthrinse

Active Comparator group

Description:

A mouthrinse containing chlorhexidine

Treatment:

Drug: 0.12% chlorhexidine

Placebo mouthrinse

Placebo Comparator group

Description:

A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride

Treatment:

Other: Placebo