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Interaction Between Chlorhexidine and Fluoride

Primary Purpose

Periodontal Disease, Dental Caries

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.12 % chlorhexidine + 0.2 % NaF mouthrinse
0.2 % NaF mouthrinse
0.12% chlorhexidine
Placebo
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Disease focused on measuring Prevention

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    0.12 % chlorhexidine + 0.2 % NaF mouthrinse

    0.2 % NaF mouthrinse

    0.12% chlorhexidine mouthrinse

    Placebo mouthrinse

    Arm Description

    A mouthrinse combining chlorhexidine and NaF

    A mouthrinse containing NaF

    A mouthrinse containing chlorhexidine

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

    Outcomes

    Primary Outcome Measures

    Plaque index
    Plaque index
    Plaque index
    Gingivitis index
    Gingivitis index

    Secondary Outcome Measures

    Mutans streptococci counts in dental plaque and saliva
    Mutans streptococci counts in dental plaque and saliva
    Streptococcus sanguis counts in dental plaque and saliva
    Lactobacilli counts in dental plaque and saliva
    Lactobacilli counts in dental plaque and saliva
    Lactobacilli counts in dental plaque and saliva
    Streptococcus sanguinis counts in dental plaque and saliva
    Streptococcus sanguinis counts in dental plaque and saliva
    Streptococcus sanguinis counts in dental plaque and saliva
    Total bacterial counts in dental plaque and saliva
    Total bacterial counts in dental plaque and saliva
    Total bacterial counts in dental plaque and saliva

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    October 12, 2016
    Sponsor
    University of Oslo
    Collaborators
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935322
    Brief Title
    Interaction Between Chlorhexidine and Fluoride
    Official Title
    Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo
    Collaborators
    Göteborg University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Disease, Dental Caries
    Keywords
    Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.12 % chlorhexidine + 0.2 % NaF mouthrinse
    Arm Type
    Active Comparator
    Arm Description
    A mouthrinse combining chlorhexidine and NaF
    Arm Title
    0.2 % NaF mouthrinse
    Arm Type
    Active Comparator
    Arm Description
    A mouthrinse containing NaF
    Arm Title
    0.12% chlorhexidine mouthrinse
    Arm Type
    Active Comparator
    Arm Description
    A mouthrinse containing chlorhexidine
    Arm Title
    Placebo mouthrinse
    Arm Type
    Placebo Comparator
    Arm Description
    A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride
    Intervention Type
    Drug
    Intervention Name(s)
    0.12 % chlorhexidine + 0.2 % NaF mouthrinse
    Other Intervention Name(s)
    Chlorhexidine + NaF mouthwash
    Intervention Description
    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
    Intervention Name(s)
    0.2 % NaF mouthrinse
    Other Intervention Name(s)
    NaF mouthwash
    Intervention Description
    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
    Intervention Name(s)
    0.12% chlorhexidine
    Other Intervention Name(s)
    Chlorhexidine mouthwash
    Intervention Description
    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
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    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 Outcome Measure Information:
    Title
    Plaque index
    Time Frame
    Baseline
    Title
    Plaque index
    Time Frame
    Day 4
    Title
    Plaque index
    Time Frame
    Day 42
    Title
    Gingivitis index
    Time Frame
    Baseline
    Title
    Gingivitis index
    Time Frame
    Day 42
    Secondary Outcome Measure Information:
    Title
    Mutans streptococci counts in dental plaque and saliva
    Time Frame
    Day 0
    Title
    Mutans streptococci counts in dental plaque and saliva
    Time Frame
    Day 4
    Title
    Streptococcus sanguis counts in dental plaque and saliva
    Time Frame
    Day 42
    Title
    Lactobacilli counts in dental plaque and saliva
    Time Frame
    Day 0
    Title
    Lactobacilli counts in dental plaque and saliva
    Time Frame
    Day 4
    Title
    Lactobacilli counts in dental plaque and saliva
    Time Frame
    Day 42
    Title
    Streptococcus sanguinis counts in dental plaque and saliva
    Time Frame
    Day 0
    Title
    Streptococcus sanguinis counts in dental plaque and saliva
    Time Frame
    Day 4
    Title
    Streptococcus sanguinis counts in dental plaque and saliva
    Time Frame
    Day 42
    Title
    Total bacterial counts in dental plaque and saliva
    Time Frame
    Day 0
    Title
    Total bacterial counts in dental plaque and saliva
    Time Frame
    Day 4
    Title
    Total bacterial counts in dental plaque and saliva
    Time Frame
    Day 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Per Ramberg, Professor
    Organizational Affiliation
    Göteborg University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    4532119
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3422503
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    266752
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    6585909
    Citation
    Dahlen G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42.
    Results Reference
    background
    PubMed Identifier
    292158
    Citation
    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.
    Results Reference
    background

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    Interaction Between Chlorhexidine and Fluoride

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