Supragingival Plaque Removal With and Without Dentifrice

Dental Plaque Clinical Trial

Official title:

Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986972
• Other study ID #: RAntoniazzi
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2013
• Last updated: November 12, 2013
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: Franciscan University Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 28 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Other:
• Toothbrushing With Dentifrice
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.
• 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.

Locations

Country	Name	City	State
Brazil	School of Dentistry, Franciscan University Center	Santa Maria	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Franciscan University Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental plaque	The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.	Three days	No