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

Gingival Abrasion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125007
• Other study ID #: FranciscanUC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 14, 2010
• Last updated: May 17, 2010
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2009
• Source: Franciscan University Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Biofilm Removal
• Gingival Abrasion

Intervention

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.

Locations

Country	Name	City	State
Brazil	Franciscan Universtity center	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Franciscan University Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Presence of gingival abrasion	Yes