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Efficacy of Different Chlorhexidine Concentrations

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ClinicalTrials.gov Identifier: NCT02911766
Recruitment Status : Unknown
Verified October 2016 by Hans Ragnar Preus, University of Oslo.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hans Ragnar Preus, University of Oslo

Brief Summary:

Chlorhexidine is the gold standard of dental plaque prevention, but which concentration is the most effective is not known. The aim of the present study was to compare the plaque and gingivitis inhibiting effect of commercial products containing 0.2%, 0.12% and 0.06% chlorhexidine in a modified experimental gingivitis model.

In three groups of healthy volunteers, experimental gingivitis was induced and monitored over 21days, simultaneously treated with the commercial solutions containing 0.2%, 0.12% and 0.06% chlorhexidine. The maxillary right quadrant of each individual received mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene. Compliance and side effects were monitored at days 7, 14, and 21. Plaque and gingivitis scores were obtained at baseline and day 21.

The commercial mouthwash containing 0.2% chlorhexidine resulted in statistically significantly lower plaque scores than the 0.12 and 0.06% mouthwashes after 21 days use, whereas no statistically significant difference was found between the effect of the two latter mouthrinses.

A commercial available mouthwash containing 0.2% chlorhexidine proved statistically significant better effect in preventing dental plaque than 0.12% and 0.06% solutions.


Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: Chlorhexidine 0.2% Mouthrinse Drug: Chlorhexidine 0.12% mouthrinse Drug: Chlorhexidine 0.06% mouthrinse Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparing the Effect of 0,06 % -, 0,12 % and 0,2 % Chlorhexidine on Plaque, Bleeding and Side Effects in an Experimental Gingivitis Model. A Parallel, Double Masked, Randomized, Placebo-controlled Clinical Trial
Study Start Date : November 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Corsodyl, 0.2% mouthrinse

The comparator solution was Corsodyl, 0.2% Chlorhexidine mouthrinse,

Intervention Rinsing 60 sec with Comparator solution twice daily for 21 days

Drug: Chlorhexidine 0.2% Mouthrinse
Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
Other Name: Corsodyl 0.2% Chlorhexidine mouthwash

Experimental: FluxProKlorhexidine 0.12% mouthrinse

The experimental solution was FluxProChlorhexidine 0.12% mouthrinse

Intervention Rinsing 60 sec with test solution twice daily for 21 days

Drug: Chlorhexidine 0.12% mouthrinse
Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
Other Name: FluxProChlorhexidine 0.12%

Experimental: Corsodaily 0.06% mouthrinse

The second experimental solution was Corsodaily, 0.06% chlorhexidine mouthrinse.

Intervention Rinsing 60 sec with test solution twice daily for 21 days

Drug: Chlorhexidine 0.06% mouthrinse
Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
Other Name: Corsodaily 0.06% chlorhexidine mouthwash




Primary Outcome Measures :
  1. Plaque index of Silness and Loe (PI) 1964 [ Time Frame: 21 days ]

    0= No plaque

    1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
    2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
    3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.


Secondary Outcome Measures :
  1. Gingival index of Løe (GI) and Silness 1963 [ Time Frame: 21 days ]

    0 No inflammation.

    1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
    2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
    3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.


Other Outcome Measures:
  1. Side effects [ Time Frame: 21 days ]
    All reported side subjective side effects like "taste perturbation" (Yes/No) "numbness" (Yes/No) "soar tongue tip" (Yes/No) "Mucosal ulcers" (yes/No)

  2. subjective and objective discoloration of teeth [ Time Frame: 21 days ]
    Discoloration of dental surfaces (Yes/No)



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-smoking subjects,
  • healthy subjects
  • having at least three of the following teeth in maxillary right and left quadrant: the canine, 1st bicuspid, 2nd bicuspid, 1st molar,
  • healthy gingiva and periodontium

Exclusion Criteria:

  • pregnancy
  • lactation
  • any chronic diseases
  • clinical signs or symptoms of acute infection in the oral cavity
  • any prescribed or non-prescription systemic or topical medication except oral contraceptives
  • use of systemic antibiotics the last 3 months prior to the start of the study history of alcohol or drug abuse
  • participation in other clinical studies in the last 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911766


Contacts
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Contact: Hans R Preus, PhD +47 22852163 hpreus@odont.uio.no
Contact: Jan E Ellingsen, PhD +4722852141 j.e.e@odont.uio.no

Locations
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Norway
Department of Periodontology, Institute of Clinical Odontology, Dental Faculty, University of Oslo
Oslo, Norway, 0455
Sponsors and Collaborators
University of Oslo
Investigators
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Principal Investigator: Hans R Preus, PhD Department of periodontics, Dental Faculty, UiO

Publications of Results:

Other Publications:
Denton, G. W. Disinfection, Sterilization and Preservation, 4th ed, pp. 274-89.
Altman DG. Clinical trials. Practical statistics for medical research. London: Chapman & Hall/CRC; 1991. p 456.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hans Ragnar Preus, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02911766     History of Changes
Other Study ID Numbers: 2015/608453
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via Scientific Journals
Keywords provided by Hans Ragnar Preus, University of Oslo:
Periodontal Index
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents