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

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Autologous connective tissue graft with rotated papilla flap; Device: Collagen matrix construct (Mucograft)

• Registration Number: NCT01440426
• Lead Sponsor: Maurizio Tonetti

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous connective tissue graft	Autologous connective tissue graft with rotated papilla flap	Soft tissue harvested from patient palate
Collagen Matrix Construct	Collagen matrix construct (Mucograft)	Mucograft collagen matrix manufactured by Geistlich AG, Switzerland

Primary Outcome Measures

Name	Time	Method
Time to recovery after surgery	3 months	Time to recover after surgery assessed by diary and post'op follow up professional assessment

Secondary Outcome Measures

Name	Time	Method
Complete root coverage	6 months	Frequency of complete root coverage
Percentage of root coverage	6 months	Percentage of the exposed tooth root covered after surgical intervention
Esthetics	6 months	Professional assessment by blind assessor of the esthetic result

Trial Locations

Locations (13)

Clinic Fourmousis; 🇬🇷 Athens, Greece

ICPDOI; 🇧🇪 Brussels, Belgium

Praxis Dr. Halben; 🇩🇪 Hamburg, Germany

Praxis Prof Wachtel - Dr Bolz; 🇩🇪 Munich, Germany

Clinia Zabalegui; 🇪🇸 Bilbao, Spain

Praxis Prof Huerzeler - Dr Zuhr; 🇩🇪 Munich, Germany

University of FLorence; 🇮🇹 Florence, Italy

Praxis Prof. Topoll; 🇩🇪 Munster, Germany

Practice Prof Giulio Rasperini; 🇮🇹 Piacenza, Italy

University of Pisa; 🇮🇹 Pisa, Italy

Clinica Guerrero; 🇪🇸 Malaga, Spain

Praxis Burkhardt; 🇨🇭 Zurich, Switzerland

Praxis Wallkamm; 🇨🇭 Langenthal, Switzerland