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CompletedNCT01125007Updated May 18, 2010

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

A Phase 1/2 interventional study of Two kind toothbrushes in Biofilm Removal and Gingival Abrasion, sponsored by Franciscan University Center. Completed at 1 site in Brazil. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-18.

Sponsored by Franciscan University Center · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Biofilm Removal
  • Gingival Abrasion

Keywords

  • Dental plaque
  • Gingival abrasion
  • toothbrushing
03

In context

Lead sponsor

Franciscan University Center is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceTwo 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.

06

What researchers measure

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.

    Time frame: Presence of gingival abrasion

07

Study locations

1 site
  • Franciscan Universtity center
    Santa Maria, RS 97050730, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01125007
Lead sponsor
Franciscan University Center
First posted
May 18, 2010
Start date
Jan 2009
Primary completion
May 2010
Completion
May 2010
Last update
May 18, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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