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Supragingival Plaque Removal With and Without Dentifrice

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Toothbrushing With Dentifrice
Toothbrushing Without Dentifrice
Sponsored by
Franciscan University Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Toothbrushing, Dental plaque, Dentifrice, Oral hygiene

Eligibility Criteria

17 Years - 28 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Dentistry, Franciscan University Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Toothbrushing With Dentifrice

Toothbrushing Without Dentifrice

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 9, 2013
Last Updated
November 12, 2013
Sponsor
Franciscan University Center
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1. Study Identification

Unique Protocol Identification Number
NCT01986972
Brief Title
Supragingival Plaque Removal With and Without Dentifrice
Official Title
Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franciscan University Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Toothbrushing, Dental plaque, Dentifrice, Oral hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toothbrushing With Dentifrice
Arm Type
Active Comparator
Arm Description
After 72 hours of absence oral hygiene, patients performed toothbrushing with common dentifrice.
Arm Title
Toothbrushing Without Dentifrice
Arm Type
Experimental
Arm Description
After 72 hours of absence oral hygiene, patients performed toothbrushing without dentifrice.
Intervention Type
Other
Intervention Name(s)
Toothbrushing With Dentifrice
Other Intervention Name(s)
Brushed with multi bristle brush, Dentifrice closeUp
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Toothbrushing Without Dentifrice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental plaque
Description
The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.
Time Frame
Three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
School of Dentistry, Franciscan University Center
City
Santa Maria
State/Province
Rio Grande do Sul
ZIP/Postal Code
97010-491
Country
Brazil

12. IPD Sharing Statement

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Supragingival Plaque Removal With and Without Dentifrice

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