Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440426
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
The European Research Group on Periodontology (ERGOPerio)
Information provided by (Responsible Party):
Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)

Brief Summary:
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 or disease Intervention/treatment Phase
Gingival Recession Procedure: Autologous connective tissue graft with rotated papilla flap Device: Collagen matrix construct (Mucograft) Phase 4

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to recovery after surgery [ Time Frame: 3 months ]
    Time to recover after surgery assessed by diary and post'op follow up professional assessment


Secondary Outcome Measures :
  1. Complete root coverage [ Time Frame: 6 months ]
    Frequency of complete root coverage

  2. Percentage of root coverage [ Time Frame: 6 months ]
    Percentage of the exposed tooth root covered after surgical intervention

  3. Esthetics [ Time Frame: 6 months ]
    Professional assessment by blind assessor of the esthetic result



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440426


Locations
Layout table for location information
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
Layout table for investigator information
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)
Layout table for additonal information
Responsible Party: Maurizio Tonetti, Executive DIrector, The European Research Group on Periodontology (ERGOPerio)
ClinicalTrials.gov Identifier: NCT01440426    
Other Study ID Numbers: ERGOPerio 11-01
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio):
gingival recession
root coverage
periodontal surgery
collagen matrix
mucograft
multiple exposed teeth
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy