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Completed

NCT Number: NCT00818376

Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental prophylaxis

Other

Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.

Primary outcomes

  1. Dental Staining

    Time frame: 21 days

Secondary outcomes

  1. Dental calculus formation

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Lutheran University of Brazil

Other

Registry information

Official study title

Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.

Important dates

Study start
2006
Primary completion
2006
Study completion
2008
First posted
Jan 7, 2009
Registry last updated
Jan 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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