Supragingival Plaque Removal With and Without Dentifrice

NCT01986972 | Completed Phase 2 DMC

• 1 other identifier: RAntoniazzi
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Plaque

Keywords

Toothbrushing; Dental plaque; Dentifrice; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• Dental plaque

  The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.

  Three days

Study Arms (2)

Toothbrushing With Dentifrice

ACTIVE COMPARATOR

After 72 hours of absence oral hygiene, patients performed toothbrushing with common dentifrice.

Other: Toothbrushing With Dentifrice

Toothbrushing Without Dentifrice

EXPERIMENTAL

After 72 hours of absence oral hygiene, patients performed toothbrushing without dentifrice.

Other: Toothbrushing Without Dentifrice

Interventions

Toothbrushing With Dentifrice OTHER

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.

Also known as: Brushed with multi bristle brush, Dentifrice closeUp

Toothbrushing With Dentifrice

Toothbrushing Without Dentifrice OTHER

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.

Toothbrushing Without Dentifrice

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• students of both genders systemically healthy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscan University Center: lead

Study Sites (1)

School of Dentistry, Franciscan University Center

Santa Maria, Rio Grande do Sul, 97010-491, Brazil

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothbrushing; Dentifrices

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry; Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial

Study Record Dates

• First Submitted: March 9, 2013
• First Posted: November 19, 2013
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

BR (1)