- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125007
Capacity of Biofilm Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
May 17, 2010 updated by: Franciscan University Center
Biofilm Capacity Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Santa Maria, RS, Brazil, 97050730
- Franciscan Universtity center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Presence of gingival abrasion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 14, 2010
First Submitted That Met QC Criteria
May 17, 2010
First Posted (Estimate)
May 18, 2010
Study Record Updates
Last Update Posted (Estimate)
May 18, 2010
Last Update Submitted That Met QC Criteria
May 17, 2010
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FranciscanUC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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