Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by The European Research Group on Periodontology (ERGOPerio).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
The European Research Group on Periodontology (ERGOPerio)
Information provided by (Responsible Party):
Maurizio Tonetti, European Research Group on Periodontology
ClinicalTrials.gov Identifier:
NCT01440426
First received: September 22, 2011
Last updated: September 23, 2011
Last verified: September 2011
  Purpose
This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.

Condition Intervention Phase
Gingival Recession
Procedure: Autologous connective tissue graft with rotated papilla flap
Device: Collagen matrix construct (Mucograft)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Connective Tissue Graft vs Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects Randomized Controlled Clinical Trial Assessing Superiority in Health Related Quality of Life and Non-Inferiority in Root Coverage

Further study details as provided by The European Research Group on Periodontology (ERGOPerio):

Primary Outcome Measures:
  • Time to recovery after surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Time to recover after surgery assessed by diary and post'op follow up professional assessment


Secondary Outcome Measures:
  • Complete root coverage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Frequency of complete root coverage

  • Percentage of root coverage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of the exposed tooth root covered after surgical intervention

  • Esthetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Professional assessment by blind assessor of the esthetic result


Estimated Enrollment: 280
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autologous connective tissue graft
Soft tissue harvested from patient palate
Procedure: Autologous connective tissue graft with rotated papilla flap
Subepithelial connective tissue graft harvested from hard palate
Other Name: Subepithelial connective tissue graft
Experimental: Collagen Matrix Construct
Mucograft collagen matrix manufactured by Geistlich AG, Switzerland
Device: Collagen matrix construct (Mucograft)
Mucograft Collagen Matrix combined with rotated papilla flap
Other Name: Mucograft gingival augmentation

Detailed Description:

Objectives The main objective of this study is to assess if the Mucograft Collagen Matrix reduces morbidity, shortens time to recovery and improves patient based outcomes with respect to the use of autologous connective tissue graft harvested from the patient own palate when used to obtain root coverage of multiple adjacent gingival recessions.

The secondary objective is to assess the non-inferiority - in terms of complete root coverage, percentage of root coverage and professional evaluation of aesthetics - of the use of Mucograft Collagen Matrix and autologous connective tissue harvested from the patient's own palate.

Design and Outcomes This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, multinational, clinical trial.

The statistical design will be a superiority trial in terms of the primary outcomes (patient based outcomes) and non-inferiority trial in terms of the professional outcomes measuring root coverage and aesthetics.

Sample size has been estimated in 140 subjects per treatment arm using a pilot case series analyzed with a multilevel statistical approach and a non inferiority margin of 0.25 mm in recession coverage.

Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factor cigarette smoking. Allocation will be concealed to the surgeons until completion of preparation of the recipient bed by opaque envelopes. A central study registrar will perform patient registration.

Study locations will include academic centers and a practice-based research network in Italy, Switzerland, Germany, Belgium, France, Spain and Greece.

A single examiner, blind with respect to the treatment assignment, will perform all measurements at each center. Trained personnel not involved with the surgical intervention will: i) administer patient questionnaires, ii) provide instructions and collect patient diaries. A single calibrated investigator with specific experience in using the specific score will centrally perform assessment of esthetic scores on standardized digital images.

A biostatistician blind with respect to treatment assignment will perform the analysis.

Interventions and Duration The two intervention groups will consist of surgery with connective tissue graft (standard of care control) and surgery with the application of Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment consisting of root coverage surgery using coronally advanced flaps, the most utilized procedure for coverage of multiple recessions. Surgery will be standardized and the same procedures/materials will be employed to ensure consistency.

Follow-up of individual patients will be 6 months (to be extended to 3 years if funding will be available)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2-4 adjacent gingival recession (one at least 3 mm deep)

Exclusion Criteria:

  • Interdental attachment loss greater than 1 mm at recession sites
  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: NCT01440426

Locations
Belgium
ICPDOI
Brussels, Belgium
Germany
Praxis Dr. Halben
Hamburg, Germany
Praxis Prof Huerzeler - Dr Zuhr
Munich, Germany
Praxis Prof Wachtel - Dr Bolz
Munich, Germany
Praxis Prof. Topoll
Munster, Germany
Greece
Clinic Fourmousis
Athens, Greece
Italy
University of FLorence
Florence, Italy
Practice Prof Giulio Rasperini
Piacenza, Italy
University of Pisa
Pisa, Italy
Spain
Clinia Zabalegui
Bilbao, Spain
Clinica Guerrero
Malaga, Spain
Switzerland
Praxis Wallkamm
Langenthal, Switzerland
Praxis Burkhardt
Zurich, Switzerland
Sponsors and Collaborators
Maurizio Tonetti
The European Research Group on Periodontology (ERGOPerio)
Investigators
Principal Investigator: Maurizio Tonetti, DMD PhD The European Research Group on Periodontology (ERGOPerio)
Principal Investigator: Pierpaolo COrtellini, MD The European Research Group on Periodontology (ERGOPerio)
  More Information

Responsible Party: Maurizio Tonetti, Executive DIrector, European Research Group on Periodontology
ClinicalTrials.gov Identifier: NCT01440426     History of Changes
Other Study ID Numbers: ERGOPerio 11-01 
Study First Received: September 22, 2011
Last Updated: September 23, 2011
Health Authority: Belgium: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Spain: Ethics Committee

Keywords provided by The European Research Group on Periodontology (ERGOPerio):
gingival recession
root coverage
periodontal surgery
collagen matrix
mucograft
multiple exposed teeth

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

ClinicalTrials.gov processed this record on December 09, 2016