The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial

July 5, 2012 updated by: Bruna Frizon Greggianin, Federal University of Rio Grande do Sul

The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized

The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.

This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

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
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035003
        • Federal University of Rio Grande do Sul

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

14 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • good/ excellent health;
  • idade de 14 a 20 anos;
  • at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
  • absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.

Exclusion Criteria:

  • were unable to provide consent or comply with the sudy protocol;
  • smokers;
  • pregnant women;
  • persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
  • need of antibiotic prophylaxis associated with dental procedures.

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Toothbrush type - medium
This is a crossover study, where the person used either a soft brush (control) and the medium brush (test).
Device: Toothbrush type
Evaluate the use of toothbrushes with bristles soft and medium
ACTIVE_COMPARATOR: Toothbrush type - soft
This is a crossover study, where the person used either a soft brush (control)and the medium brush(test).
Device: Toothbrush type
Evaluate the use of toothbrushes with bristles soft and medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Fissures associated with toothbrushing
Time Frame: 3 months
This study took standardized photographs every 2 or 3 days during two periods of 28 days for evaluation of gingival fissures. These were measured by application of a disclosing solution of plaque on teeth and gums of the participants. The application developer board is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (ESTIMATE)

July 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR 001

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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