Interaction Between Chlorhexidine and Fluoride

NCT02935322 | Completed Phase 4

• 1 other identifier: Dnr 745-11
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Disease; Dental Caries

Keywords

Prevention

Outcome Measures

Primary Outcomes (5)

• Plaque index

  Baseline

• Plaque index

  Day 4

• Plaque index

  Day 42

• Gingivitis index

  Baseline

• Gingivitis index

  Day 42

Secondary Outcomes (12)

• Mutans streptococci counts in dental plaque and saliva

  Day 0

• Mutans streptococci counts in dental plaque and saliva

  Day 4

• Streptococcus sanguis counts in dental plaque and saliva

  Day 42

• Lactobacilli counts in dental plaque and saliva

  Day 0

• Lactobacilli counts in dental plaque and saliva

  Day 4

Study Arms (4)

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

ACTIVE COMPARATOR

A mouthrinse combining chlorhexidine and NaF

Drug: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse

0.2 % NaF mouthrinse

ACTIVE COMPARATOR

A mouthrinse containing NaF

Drug: 0.2 % NaF mouthrinse

0.12% chlorhexidine mouthrinse

ACTIVE COMPARATOR

A mouthrinse containing chlorhexidine

Drug: 0.12% chlorhexidine

Placebo mouthrinse

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Also known as: Chlorhexidine + NaF mouthwash

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

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.

Also known as: NaF mouthwash

0.2 % NaF mouthrinse

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.

Also known as: Chlorhexidine mouthwash

0.12% chlorhexidine mouthrinse

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.

Placebo mouthrinse

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Göteborg University: collaborator

Related Publications (5)

• 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.

  PMID: 4532119 BACKGROUND

• 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.

  PMID: 3422503 BACKGROUND

• 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.

  PMID: 266752 BACKGROUND

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

  PMID: 6585909 BACKGROUND

• 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.

  PMID: 292158 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Dental Caries

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Per Ramberg, Professor

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 17, 2016
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 17, 2016

Record last verified: 2016-10