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Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

Primary Purpose

Dental Calculus, Tooth Discoloration

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dental prophylaxis
Sponsored by
Lutheran University of Brazil
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Calculus focused on measuring Chlorhexidine, adverse effects, staining, dental calculus, dental plaque

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18-35 years
  • Male
  • No relevant medical conditions that could interfere on the periodontal health
  • Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites
  • Willingness to comply

Exclusion Criteria:

  • Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination
  • Oral mucosal lesions
  • Smokers
  • Need for antibiotic premedication
  • History of hypersensitivity to chlorhexidine
  • Any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses)

Exclusion criteria during the study:

  • Individuals that wanted to give up the study
  • Any acute process like allergic reaction to the product or gingival abcess
  • Necessity to use of any antibiotic or anti-inflammatory
  • Use of any other rinsing product farther the chlorhexidine's rinses
  • Individuals who did any mechanical biofilm control

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Dental Staining

    Secondary Outcome Measures

    Dental calculus formation

    Full Information

    First Posted
    January 6, 2009
    Last Updated
    January 29, 2009
    Sponsor
    Lutheran University of Brazil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00818376
    Brief Title
    Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
    Official Title
    Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Lutheran University of Brazil

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. The purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.
    Detailed Description
    Test panel The test panel will be recruited from the dental students of the Lutheran University of Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their medical and dental history. Written and oral explanations detailing the study purpose and design will be given for each subject. Subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. If the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers. The following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar. Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - Absence of calculus; 1 - Presence of calculus. Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Calculus, Tooth Discoloration
    Keywords
    Chlorhexidine, adverse effects, staining, dental calculus, dental plaque

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Dental prophylaxis
    Intervention Description
    Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
    Primary Outcome Measure Information:
    Title
    Dental Staining
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Dental calculus formation
    Time Frame
    21 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 18-35 years Male No relevant medical conditions that could interfere on the periodontal health Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites Willingness to comply Exclusion Criteria: Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination Oral mucosal lesions Smokers Need for antibiotic premedication History of hypersensitivity to chlorhexidine Any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses) Exclusion criteria during the study: Individuals that wanted to give up the study Any acute process like allergic reaction to the product or gingival abcess Necessity to use of any antibiotic or anti-inflammatory Use of any other rinsing product farther the chlorhexidine's rinses Individuals who did any mechanical biofilm control

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21085810
    Citation
    Zanatta FB, Antoniazzi RP, Rosing CK. Staining and calculus formation after 0.12% chlorhexidine rinses in plaque-free and plaque covered surfaces: a randomized trial. J Appl Oral Sci. 2010 Sep-Oct;18(5):515-21. doi: 10.1590/s1678-77572010000500015.
    Results Reference
    derived

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    Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

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