Staining and Calculus Formation After 0.12% Chlorhexidine Rinses - Full Text View

Sponsored by:	Lutheran University of Brazil
Information provided by:	Lutheran University of Brazil
ClinicalTrials.gov Identifier:	NCT00818376

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 II

Drug Information available for: Chlorhexidine Chlorhexidine digluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.

Further study details as provided by Lutheran University of Brazil:

Primary Outcome Measures:

Dental Staining [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Dental calculus formation [ 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:

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

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

Keywords provided by Lutheran University of Brazil:

Chlorhexidine
adverse effects
staining
tooth discoloration

dental calculus
dental plaque
The purpose of this study was to compare staining and calculus formation after 0.12% chlorhexidine between previously plaque-free and plaque-covered surfaces.

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Tooth Discoloration

Stomatognathic Diseases
Calculi
Dental Plaque
Dental Calculus

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Dental Deposits

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009