- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01986972
Supragingival Plaque Removal With and Without Dentifrice
Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial
Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial.
Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by paired sample t test.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
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Santa Maria, Rio Grande do Sul, Brazil, 97010-491
- School of Dentistry, Franciscan University Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- students of both genders systemically healthy.
Exclusion Criteria:
- individuals who exhibited gingivitis (presence of gingival bleeding at any site);
- probing depth > 3mm and/or attachment loss >3mm at any site;
- using orthodontic appliance devices, dental prostheses, dental implants;
- presence of abrasions, restorations and/or carious lesions at cervical region;
- individuals who had less than 20 natural teeth.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Toothbrushing With Dentifrice
After 72 hours of absence oral hygiene, patients performed toothbrushing with common dentifrice.
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The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours.
Dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute.
Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin.
One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice.
Toothbrushing was performed by the individual's regular technique timed.
Two minutes was used for each set.
After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
Other Names:
|
|
Experimental: Toothbrushing Without Dentifrice
After 72 hours of absence oral hygiene, patients performed toothbrushing without dentifrice.
|
The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours.
Then, dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute.
Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin.
One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice.
Toothbrushing was performed by the individual's regular technique timed.
Two minutes was used for each set.
After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental plaque
Time Frame: Three days
|
The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.
|
Three days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAntoniazzi
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