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

Primary Purpose

Gingival Recession, Wounds and Injuries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Toothbrush type
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gingival Recession focused on measuring Toothbrushing, gingival recession

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Toothbrush type - medium

Toothbrush type - soft

Arm Description

This is a crossover study, where the person used either a soft brush (control) and the medium brush (test).

This is a crossover study, where the person used either a soft brush (control)and the medium brush(test).

Outcomes

Primary Outcome Measures

Gingival Fissures associated with toothbrushing
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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2012
Last Updated
July 5, 2012
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01636830
Brief Title
The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial
Official Title
The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Wounds and Injuries
Keywords
Toothbrushing, gingival recession

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toothbrush type - medium
Arm Type
Active Comparator
Arm Description
This is a crossover study, where the person used either a soft brush (control) and the medium brush (test).
Arm Title
Toothbrush type - soft
Arm Type
Active Comparator
Arm Description
This is a crossover study, where the person used either a soft brush (control)and the medium brush(test).
Intervention Type
Device
Intervention Name(s)
Toothbrush type
Intervention Description
Evaluate the use of toothbrushes with bristles soft and medium
Primary Outcome Measure Information:
Title
Gingival Fissures associated with toothbrushing
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035003
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23425194
Citation
Greggianin BF, Oliveira SC, Haas AN, Oppermann RV. The incidence of gingival fissures associated with toothbrushing: crossover 28-day randomized trial. J Clin Periodontol. 2013 Apr;40(4):319-26. doi: 10.1111/jcpe.12072. Epub 2013 Feb 21.
Results Reference
derived
Links:
URL
http://www.ufrgs.br/odonto
Description
Website of the Federal University of Rio Grande do Sul

Learn more about this trial

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

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