Capacity of Biofilm Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes

This study has been completed.
Sponsor:
Information provided by:
Franciscan University Center
ClinicalTrials.gov Identifier:
NCT01125007
First received: May 14, 2010
Last updated: May 17, 2010
Last verified: January 2009
  Purpose

This study compared the removal of dental biofilm between soft and medium toothbrushes. The patients refrained from performing mechanical or chemical plaque control for 96 hours to allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm formation, the quadrants were randomized and the participants brushed different quadrants with soft and medium toothbrushes, with or without dentifrice. The plaque indices were analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al. (1970).


Condition Intervention Phase
Biofilm Removal
Gingival Abrasion
Device: Two kind toothbrushes
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Biofilm Capacity Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes

Further study details as provided by Franciscan University Center:

Primary Outcome Measures:
  • Gingival abrasion [ Time Frame: Presence of gingival abrasion ] [ Designated as safety issue: Yes ]
    All gingival quadrants were analised by photographs made in different experimental times. After that, all photographs were evaluated in a blinded manner, according to the methodology suggested by Danser, et al. (1998), dividing the region to be analyzed in three areas: cervical, interdental and mid-gingival. In each area, the presence of gingival abrasion was assessed dichotomically.


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: toothbrush
a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.
Device: Two kind toothbrushes
a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.
Experimental: medium toothbrush
a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.
Device: Two kind toothbrushes
a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study was conducted on 25 participants selected among undergraduate dental students of UNIFRA (Santa Maria, Rio Grande do Sul, Brazil)
  • Males and Females
  • All systemically healthy
  • Aged 18 to 30 years (mean age 21.4 ± 3.9 years) with at least 20 present teeth

Exclusion Criteria:

  • The exclusion criteria comprised presence of sites with attachment loss ≥ 2mm
  • Orthodontic appliances
  • Prostheses
  • Dental implants
  • Aabrasions, restorations and/or carious lesions on the cervical region
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125007

Locations
Brazil
Franciscan Universtity center
Santa Maria, RS, Brazil, 97050730
Sponsors and Collaborators
Franciscan University Center
  More Information

No publications provided

Responsible Party: Ana Maria Chagas, coordinator
ClinicalTrials.gov Identifier: NCT01125007     History of Changes
Other Study ID Numbers: FranciscanUC
Study First Received: May 14, 2010
Last Updated: May 17, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Franciscan University Center:
Dental plaque
Gingival abrasion
toothbrushing

ClinicalTrials.gov processed this record on April 17, 2014