A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions (MCT-Recession)

February 6, 2019 updated by: Geistlich Pharma AG

A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.

The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assumed that the CAF combined with Mucograft® will result in improved outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF alone (control).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' esthetic demands.

Many surgical techniques have been utilized to restore gingival tissue dimensions including the use of autologous soft tissue graft. Longitudinal studies have shown that procedures using pedicle and free grafts are both effective for this purpose. However, since this technique uses epithelialized grafts, it generally results in compromised aesthetics ("patch-like area"). Alternatively free connective tissue grafts (CTG) are used providing similar predictability but resulting in better colour matching. Unfortunately, both techniques are associated with significant patient morbidity due to the wound at the palatal donor site. To avoid patient morbidity, acellular dermal allografts have been used as substitutes for palatal donor tissue, demonstrating the possible and promising use of allograft material. However, since the allograft material is derived from human cadavers; it is associated with ethical concerns and the risk of disease transmission.

In patients with a residual amount of keratinized tissue, the coronally advanced flap (CAF) - first introduce by Norber et al. (1926) - has been demonstrated to be very effective in treatment of multiple and single recessions with advantages in terms of aesthetics and morbidity. Although CAF is a safe and predictable approach for root coverage, the application of this surgical technique in conjunction with autologous or synthetic material was reported to enhance the probability to achieve complete root coverage in Miller Class I and II gingival recessions. A promising option to avoid patient morbidity and the use of autologous transplants or allografts is the use of collagen matrices from porcine origin, such as Mucograft®. Similar devices have been extensively used for guided tissue regeneration procedures. Mucograft® provides an ideal matrix for blood vessel and soft tissue ingrowth, which is likely to improve the results and the predictability of recession coverage procedure using the CAF.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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

  • Spain
      • Madrid, Spain, 2804
        • Prof. Mariano Sanz

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient (male or female) must be 18 years or older
  • The patient must be a candidate for bilateral root coverage procedure
  • Recession defects are Miller Class I-II and do not vary more than 2 mm.
  • At least one mm keratinized tissue is present.
  • Patient shows sufficient plaque control (FMPS < 20%).
  • If patient is of child-bearing potential, the patient confirms not to be pregnant and agrees to take contraception for at least 6 months after surgery.
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

Exclusion Criteria:

  • Patient is a heavy smoker (> 10 cigarettes per day)
  • Patient is an insulin dependent diabetic
  • General contraindications for dental and/or surgical treatment are present.
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
  • The patient is pregnant or nursing
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
  • The patient has a disease, which affects connective tissue metabolism (e.g. collagenases).
  • The patient is allergic to collagen.
  • Patients have participated in a clinical trial within the last six months.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucograft + CAF
Mucograft in combination with coronally advanced flap (CAF)
Device: Mucograft
Collagen Matrix for soft tissue regeneration
Experimental: CAF
Coronally advanced flap (CAF) alone
Procedure: Coronally advanced flap (CAF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of root coverage
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
gingival thickness
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Geistlich Pharma AG

Investigators

  • Principal Investigator: Mariano Sanz, Prof., Department of Periodontology, University Complutense Madrid, Spain
  • Principal Investigator: Soren Jepsen, Prof., Department of Periodontology, University of Bonn, Germany
  • Principal Investigator: Jan Wennström, Prof., Department of Periodontology, University of Gothenburg, Sweden
  • Principal Investigator: Giovanni Zucchelli, Prof., Department of Periodontology, University of Bologna, Italy
  • Study Director: Lorenz Uebersax, Dr., Geistlich Pharma AG, Wolhusen, Switzerland
  • Principal Investigator: Bernd Heinz, Dr, Private practice Hamburg, Germany
  • Principal Investigator: Massimo DeSanctis, Prof., Private Practice Firenze

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, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10812-009

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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