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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Franciscan University Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings