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Completed

NCT Number: NCT02935322

Interaction Between Chlorhexidine and Fluoride

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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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

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.

Other names: Chlorhexidine + NaF mouthwash

0.2 % NaF mouthrinse

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.

Other names: NaF mouthwash

0.12% chlorhexidine

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.

Other names: Chlorhexidine mouthwash

Placebo

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.

Primary outcomes

  1. Plaque index

    Time frame: Baseline

  2. Plaque index

    Time frame: Day 4

  3. Plaque index

    Time frame: Day 42

  4. Gingivitis index

    Time frame: Baseline

  5. Gingivitis index

    Time frame: Day 42

Secondary outcomes

  1. Mutans streptococci counts in dental plaque and saliva

    Time frame: Day 0

  2. Mutans streptococci counts in dental plaque and saliva

    Time frame: Day 4

  3. Streptococcus sanguis counts in dental plaque and saliva

    Time frame: Day 42

  4. Lactobacilli counts in dental plaque and saliva

    Time frame: Day 0

  5. Lactobacilli counts in dental plaque and saliva

    Time frame: Day 4

  6. Lactobacilli counts in dental plaque and saliva

    Time frame: Day 42

  7. Streptococcus sanguinis counts in dental plaque and saliva

    Time frame: Day 0

  8. Streptococcus sanguinis counts in dental plaque and saliva

    Time frame: Day 4

  9. Streptococcus sanguinis counts in dental plaque and saliva

    Time frame: Day 42

  10. Total bacterial counts in dental plaque and saliva

    Time frame: Day 0

  11. Total bacterial counts in dental plaque and saliva

    Time frame: Day 4

  12. Total bacterial counts in dental plaque and saliva

    Time frame: Day 42

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 17, 2016
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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