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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geistlich Pharma AG
ClinicalTrials.gov Identifier:
NCT00902876
First received: May 14, 2009
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention
Gingival Recession
Device: Mucograft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.

Further study details as provided by Geistlich Pharma AG:

Primary Outcome Measures:
  • percentage of root coverage [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gingival thickness [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mucograft + CAF
Mucograft in combination with coronally advanced flap (CAF)
Device: Mucograft
Collagen Matrix for soft tissue regeneration

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902876

Locations
Spain
Prof. Mariano Sanz
Madrid, Spain, 2804
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT00902876     History of Changes
Other Study ID Numbers: 10812-009
Study First Received: May 14, 2009
Last Updated: February 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Italy: Ministry of Health

Keywords provided by Geistlich Pharma AG:
root coverage
gingival recession
keratinized gingiva

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy

ClinicalTrials.gov processed this record on September 14, 2014