Interaction Between Chlorhexidine and Fluoride

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontal Disease Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.12 % chlorhexidine + 0.2 % NaF mouthrinse

A mouthrinse combining chlorhexidine and NaF

Group Type ACTIVE_COMPARATOR

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

Intervention Type DRUG

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

A mouthrinse containing NaF

Group Type ACTIVE_COMPARATOR

0.2 % NaF mouthrinse

Intervention Type DRUG

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 mouthrinse

A mouthrinse containing chlorhexidine

Group Type ACTIVE_COMPARATOR

0.12% chlorhexidine

Intervention Type DRUG

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.

Placebo mouthrinse

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Chlorhexidine + NaF mouthwash NaF mouthwash Chlorhexidine mouthwash

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes