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Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00818376
Enrollment
20
Registered
2009-01-07
Start date
2006-06-30
Completion date
2008-12-31
Last updated
2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Calculus, Tooth Discoloration

Keywords

Chlorhexidine, adverse effects, staining, dental calculus, dental plaque

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.

Interventions

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

Sponsors

Lutheran University of Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
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)

Design outcomes

Primary

MeasureTime frame
Dental Staining21 days

Secondary

MeasureTime frame
Dental calculus formation21 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026