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

• ClinicalTrials.gov Identifier: NCT01125007
• Recruitment Status: Completed
• First Posted: May 18, 2010
• Last Update Posted: May 18, 2010
• Sponsor: Franciscan University Center
• Information provided by: Franciscan University Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Biofilm Removal; Gingival Abrasion	Device: Two kind toothbrushes	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Biofilm Capacity Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
• Study Start Date: January 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Gingival abrasion [ Time Frame: Presence of gingival abrasion ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Brazil

Franciscan Universtity center

Santa Maria, RS, Brazil, 97050730

Sponsors and Collaborators

Franciscan University Center

More Information

• Responsible Party: Ana Maria Chagas, coordinator
• ClinicalTrials.gov Identifier: NCT01125007
• Other Study ID Numbers: FranciscanUC
• First Posted: May 18, 2010
• Last Update Posted: May 18, 2010
• Last Verified: January 2009

Keywords provided by Franciscan University Center:

Dental plaque; Gingival abrasion; toothbrushing