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Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage

NCT ID: NCT02242500

Last Updated: 2015-12-29

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.

Detailed Description

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Conditions

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Gingival Recession

Keywords

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Gingival recession/surgery Collagen/therapeutic use Root coverage Treatment outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Coronally advanced flap + Mucograft

coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft

Group Type EXPERIMENTAL

Coronally Advanced Flap

Intervention Type PROCEDURE

Mucograft

Intervention Type DEVICE

Coronally advanced flap

Coronally advanced flap procedure alone

Group Type OTHER

Coronally Advanced Flap

Intervention Type PROCEDURE

Interventions

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Coronally Advanced Flap

Intervention Type PROCEDURE

Mucograft

Intervention Type DEVICE

Other Intervention Names

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Porcine collagen matrix for soft tissue regeneration

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A + (Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).

Exclusion Criteria

* Smoking.
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Enilson Antonio Sallum

OTHER

Sponsor Role lead

Responsible Party

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Enilson Antonio Sallum

Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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130/2010

Identifier Type: -

Identifier Source: org_study_id