Treatment of Multiple Gingival Recessions

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-04-30

Brief Summary

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Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.

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Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Collagen Matrix plus coronally advanced flap (CAF)

A new collagen matrix (Mucograft) associated to coronally advanced flap

Group Type EXPERIMENTAL

Coronally advanced flap (CAF)

Intervention Type PROCEDURE

The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.

The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

Collagen Matrix

Intervention Type DRUG

A new collagen membrane

Subepithelial connective tissue graft plus CAF

Subepithelial connective tissue graft associated to coronally advanced flap

Group Type ACTIVE_COMPARATOR

Coronally advanced flap (CAF)

Intervention Type PROCEDURE

The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.

The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

Subepithelial connective tissue graft

Intervention Type PROCEDURE

Connective tissue graft

Interventions

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Coronally advanced flap (CAF)

The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.

The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

Intervention Type PROCEDURE

Collagen Matrix

A new collagen membrane

Intervention Type DRUG

Subepithelial connective tissue graft

Connective tissue graft

Intervention Type PROCEDURE

Other Intervention Names

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Subepithelial conjunctive tissue grafts Coronally advanced flaps Coronally advanced flaps associated with collagen matrix Mucograft connective tissue graft

Eligibility Criteria

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Inclusion Criteria

1. a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
2. areas of Miller's Class I or II GR;
3. teeth without root abrasions or caries.

Exclusion Criteria

* patients allergic to collagen
* a history of smoking (within the previous 6 months)
* pregnancy or lactation
* a history of destructive periodontal disease or the formation of recurrent abscesses
* root caries at the site of recession
* previous surgical root coverage procedures
* systemic healing disorders (for example, acquired immunodeficiency syndrome \[AIDS\], diabetes mellitus or risk factors evaluated by a medical doctor)
* periodontal disease, or poor plaque control (full mouth plaque index \> 20%).

1. noncarious cervical lesions (erosion, abfraction etc.)
2. any type of previous cervical restoration
3. extrusion
4. giroversion
5. mobility
6. a prominent root surface.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes