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

Not Applicable

Completed

• Conditions: Gingival Recession; Wounds and Injuries
• Interventions: Device: Toothbrush type

• Registration Number: NCT01636830
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-07
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-10
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Toothbrush type - medium	Toothbrush type	This is a crossover study, where the person used either a soft brush (control) and the medium brush (test).
Toothbrush type - soft	Toothbrush type	This is a crossover study, where the person used either a soft brush (control)and the medium brush(test).

Primary Outcome Measures

Name	Time	Method
Gingival Fissures associated with toothbrushing	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.

Trial Locations

Locations (1)

Federal University of Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil