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Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

This study has been completed.
Sponsor:
Information provided by:
Lutheran University of Brazil
ClinicalTrials.gov Identifier:
NCT00818376
First received: January 6, 2009
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Calculus
Tooth Discoloration
 Other: Dental prophylaxis
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lutheran University of Brazil:

Primary Outcome Measures:
  • Dental Staining [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dental calculus formation [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Dental prophylaxis
    Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Lutheran University of Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cassiano Kuchenbecker Rösing, Lutheran University Center
ClinicalTrials.gov Identifier: NCT00818376     History of Changes
Other Study ID Numbers: LutheranUB
Study First Received: January 6, 2009
Last Updated: January 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Lutheran University of Brazil:
Chlorhexidine
adverse effects
staining
dental calculus
dental plaque

Additional relevant MeSH terms:
Calculi
Dental Calculus
Tooth Discoloration
Pathological Conditions, Anatomical
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
 Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013