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

NCT01636830 | Completed

• 1 other identifier: BR 001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession; Wounds and Injuries

Keywords

Toothbrushing; gingival recession

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Toothbrush type - medium

ACTIVE COMPARATOR

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

Device: Toothbrush type

Toothbrush type - soft

ACTIVE COMPARATOR

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

Device: Toothbrush type

Interventions

Toothbrush type DEVICE

Evaluate the use of toothbrushes with bristles soft and medium

Toothbrush type - medium; Toothbrush type - soft

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Related Publications (1)

• 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.

  PMID: 23425194 DERIVED

Related Links

• Website of the Federal University of Rio Grande do Sul

MeSH Terms

Conditions

Gingival Recession; Wounds and Injuries

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rui Vicente Oppermann

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

BR (1)