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Periodontal DiseasePhase 4NCT02935322

Interaction Between Chlorhexidine and Fluoride

A Phase 4 study testing 0.12 % chlorhexidine + 0.2 % NaF mouthrinse, 0.2 % NaF mouthrinse and 0.12% chlorhexidine in people with Periodontal Disease and Dental Caries, run by University of Oslo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Disease, Dental Caries
What is being tested?
0.12 % chlorhexidine + 0.2 % NaF mouthrinse, 0.2 % NaF mouthrinse and 0.12% chlorhexidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
No sites listed yet
Study dates
Sep 2009to Feb 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
0.12 % chlorhexidine + 0.2 % NaF mouthrinse, 0.2 % NaF mouthrinse, 0.12% chlorhexidine, Placebo
Keywords
Prevention
Medical subject headings
Periodontal Diseases, Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.12 % chlorhexidine + 0.2 % NaF mouthrinseDrug

    Also called Chlorhexidine + NaF mouthwash

    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 mouthrinseDrug

    Also called NaF mouthwash

    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% chlorhexidineDrug

    Also called Chlorhexidine mouthwash

    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.

  • PlaceboOther

    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.

Study groups in NCT02935322
Study groupRoleWhat they receive
0.12 % chlorhexidine + 0.2 % NaF mouthrinseActive comparatorA mouthrinse combining chlorhexidine and NaF
Receives: Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse
0.2 % NaF mouthrinseActive comparatorA mouthrinse containing NaF
Receives: Drug: 0.2 % NaF mouthrinse
0.12% chlorhexidine mouthrinseActive comparatorA mouthrinse containing chlorhexidine
Receives: Drug: 0.12% chlorhexidine
Placebo mouthrinsePlacebo comparatorA mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque index

    Measured: Baseline

  2. Plaque index

    Measured: Day 4

  3. Plaque index

    Measured: Day 42

  4. Gingivitis index

    Measured: Baseline

  5. Gingivitis index

    Measured: Day 42

Secondary outcomes (12)

  1. Mutans streptococci counts in dental plaque and saliva

    Measured: Day 0

  2. Mutans streptococci counts in dental plaque and saliva

    Measured: Day 4

  3. Streptococcus sanguis counts in dental plaque and saliva

    Measured: Day 42

  4. Lactobacilli counts in dental plaque and saliva

    Measured: Day 0

  5. Lactobacilli counts in dental plaque and saliva

    Measured: Day 4

  6. Lactobacilli counts in dental plaque and saliva

    Measured: Day 42

  7. Streptococcus sanguinis counts in dental plaque and saliva

    Measured: Day 0

  8. Streptococcus sanguinis counts in dental plaque and saliva

    Measured: Day 4

  9. Streptococcus sanguinis counts in dental plaque and saliva

    Measured: Day 42

  10. Total bacterial counts in dental plaque and saliva

    Measured: Day 0

  11. Total bacterial counts in dental plaque and saliva

    Measured: Day 4

  12. Total bacterial counts in dental plaque and saliva

    Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2011
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935322
Sponsor's protocol ID
Dnr 745-11
Status last verified
Oct 2016
First submitted
10 Oct 2016
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 4532119

  • 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.

    PubMed 3422503

  • 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.

    PubMed 266752

  • Dahlen G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42.

    PubMed 6585909

  • 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.

    PubMed 292158

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.12 % chlorhexidine + 0.2 % NaF mouthrinse, 0.2 % NaF mouthrinse and 0.12% chlorhexidine in people with Periodontal Disease and Dental Caries, run by University of Oslo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque index (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935322, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.

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