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. Identifier: NCT01440426
Recruitment Status : Unknown
Verified September 2011 by Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio).
Recruitment status was:  Recruiting
First Posted : September 26, 2011
Last Update Posted : September 26, 2011
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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01440426

Contact: Gaia Pellegrini, DMD

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Principal Investigator: Francesco Cairo, DMD         
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Principal Investigator: Giulio Rasperini, DMD         
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Principal Investigator: Filippo Graziani, DMD PhD         
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Principal Investigator: Ion Zabalegui, DMD         
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Principal Investigator: Adrian Guerrero, DMD MCD         
Praxis Wallkamm Not yet recruiting
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Principal Investigator: Beat Wallkamm, DMD         
Praxis Burkhardt Not yet recruiting
Zurich, Switzerland
Principal Investigator: Rino Burkhardt, DMD         
Sponsors and Collaborators
Maurizio Tonetti
The European Research Group on Periodontology (ERGOPerio)
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)

Responsible Party: Maurizio Tonetti, Executive DIrector, The European Research Group on Periodontology (ERGOPerio) Identifier: NCT01440426     History of Changes
Other Study ID Numbers: ERGOPerio 11-01
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

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

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