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

NCT ID: NCT01125007

Last Updated: 2010-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Biofilm Removal Gingival Abrasion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Two kind toothbrushes

Intervention Type 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

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.

Group Type EXPERIMENTAL

Two kind toothbrushes

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Orthodontic appliances
* Prostheses
* Dental implants
* Aabrasions, restorations and/or carious lesions on the cervical region
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Franciscan University Center

OTHER

Sponsor Role lead

Responsible Party

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coordinator

Locations

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Franciscan Universtity center

Santa Maria, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FranciscanUC

Identifier Type: -

Identifier Source: org_study_id

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