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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by (Responsible Party):
Bruna Frizon Greggianin, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01636830
First received: July 5, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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


Condition Intervention
Gingival Recession
Wounds and Injuries
 Device: Toothbrush type

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Gingival Fissures associated with toothbrushing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636830

Locations
Brazil
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
  More Information

Additional Information:
Website of the Federal University of Rio Grande do Sul  This link exits the ClinicalTrials.gov site

No publications provided by Federal University of Rio Grande do Sul

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bruna Frizon Greggianin, Rui Vicente Oppermann, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01636830     History of Changes
Other Study ID Numbers: BR 001
Study First Received: July 5, 2012
Last Updated: July 5, 2012
Health Authority: Brazil: Federal University of Rio Grande do Sul

Keywords provided by Federal University of Rio Grande do Sul:
Toothbrushing
gingival recession

Additional relevant MeSH terms:
Gingival Recession
Wounds and Injuries
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy

ClinicalTrials.gov processed this record on June 18, 2013