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

NCT ID: NCT01636830

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Gingival Recession Wounds and Injuries

Keywords

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Toothbrushing gingival recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Toothbrush type - medium

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

Group Type ACTIVE_COMPARATOR

Toothbrush type

Intervention Type DEVICE

Evaluate the use of toothbrushes with bristles soft and medium

Toothbrush type - soft

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

Group Type ACTIVE_COMPARATOR

Toothbrush type

Intervention Type DEVICE

Evaluate the use of toothbrushes with bristles soft and medium

Interventions

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Toothbrush type

Evaluate the use of toothbrushes with bristles soft and medium

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Bruna Frizon Greggianin

Rui Vicente Oppermann

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23425194 (View on PubMed)

Related Links

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http://www.ufrgs.br/odonto

Website of the Federal University of Rio Grande do Sul

Other Identifiers

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BR 001

Identifier Type: -

Identifier Source: org_study_id