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Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

This study has been completed.
Information provided by:
Lutheran University of Brazil Identifier:
First received: January 6, 2009
Last updated: January 29, 2009
Last verified: January 2009
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
Intervention Model: Crossover Assignment
Masking: Single (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:

Further study details as provided by Lutheran University of Brazil:

Primary Outcome Measures:
  • Dental Staining [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Dental calculus formation [ Time Frame: 21 days ]

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.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cassiano Kuchenbecker Rösing, Lutheran University Center Identifier: NCT00818376     History of Changes
Other Study ID Numbers: LutheranUB
Study First Received: January 6, 2009
Last Updated: January 29, 2009

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

Additional relevant MeSH terms:
Tooth Discoloration
Dental Calculus
Pathological Conditions, Anatomical
Tooth Diseases
Stomatognathic Diseases
Dental Deposits
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents processed this record on August 18, 2017