Treatment of Multiple Gingival Recessions (3DMUCO)

January 31, 2018 updated by: Giuseppe Alexandre Romito, University of Sao Paulo

Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients will be included in the study if they fulfill the following 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: -

The exclusion criteria used will be as follows:

  • 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%).

The exclusion criteria for teeth will be:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagen Matrix plus coronally advanced flap (CAF)
A new collagen matrix (Mucograft) associated to coronally advanced flap
Procedure: 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.

Other Names:
  • Subepithelial conjunctive tissue grafts
  • Coronally advanced flaps
  • Coronally advanced flaps associated with collagen matrix
Drug: Collagen Matrix
A new collagen membrane
Other Names:
  • Mucograft
Active Comparator: Subepithelial connective tissue graft plus CAF
Subepithelial connective tissue graft associated to coronally advanced flap
Procedure: 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.

Other Names:
  • Subepithelial conjunctive tissue grafts
  • Coronally advanced flaps
  • Coronally advanced flaps associated with collagen matrix
Procedure: Subepithelial connective tissue graft
Connective tissue graft
Other Names:
  • connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of root coverage (RC)
Time Frame: 12-months
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reductions in recession depth (RRD)
Time Frame: At the baseline, 3-month, 6-month and 12-months
Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin
At the baseline, 3-month, 6-month and 12-months
Complete root coverage of the gingival recessions (CRC)
Time Frame: At the baseline, 3-month, 6-month and 12-months
At the baseline, 3-month, 6-month and 12-months
Recession width (RW) at the cemento-enamel junction
Time Frame: At the baseline, 3-month, 6-month and 12-months
At the baseline, 3-month, 6-month and 12-months
Relative clinical attachment level (RCAL)
Time Frame: At the baseline, 3-month, 6-month and 12-months
Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.
At the baseline, 3-month, 6-month and 12-months
Probing depth (PD)
Time Frame: At the baseline, 3-month, 6-month and 12-months
Calculated as RCAL- PD;
At the baseline, 3-month, 6-month and 12-months
keratinized tissue width (KT)
Time Frame: At the baseline, 3-month, 6-month and 12-months
From the free gingival margin to the mucogingival junction.
At the baseline, 3-month, 6-month and 12-months
Gain in thickness of gingival tissue (GT)
Time Frame: At the baseline, 3-month, 6-month and 12-months
With an injection needle and a silicon marker, 2mm below the gingival margin.
At the baseline, 3-month, 6-month and 12-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject esthetic satisfaction by participants
Time Frame: 1, 3, 6 months and after 12 months
The participants will be invited to reply to a questionnaire on subject esthetic satisfaction with the surgical results (from dissatisfied to very satisfied) on a scale of 1-5, as well as after 1, 3, 6 months and after 12 months.
1, 3, 6 months and after 12 months
Subjective symptoms of pain and discomfort by participants
Time Frame: At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Subjective symptoms of pain and discomfort (without pain and with a great deal of pain) will be evaluated with 10 cm (0-10) visual analog scales (VAS) at 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Esthetic questionnaire by experienced periodontist
Time Frame: 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery
One experienced periodontist will be invited to observe the initial photographs and those of the clinical results obtained during the entire healing process and asked to respond to an esthetic questionnaire (from dissatisfied to very satisfied) on a scale of 1 to 5 points after 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months.12 All this examinations also will be performed in the clinic.
1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Giuseppe Romito, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DMUCO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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