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

NCT01125007 | Completed Phase 1 DMC

• 1 other identifier: FranciscanUC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Biofilm Removal; Gingival Abrasion

Keywords

Dental plaque; Gingival abrasion; toothbrushing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

toothbrush

ACTIVE COMPARATOR

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

medium toothbrush

EXPERIMENTAL

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

Interventions

Two kind toothbrushes DEVICE

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.

medium toothbrush; toothbrush

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Orthodontic appliances
• Prostheses
• Dental implants
• Aabrasions, restorations and/or carious lesions on the cervical region

Sponsors & Collaborators

• Franciscan University Center: lead

Study Sites (1)

Franciscan Universtity center

Santa Maria, Rio Grande do Sul, 97050730, Brazil

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: January 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2009-01

Locations

BR (1)