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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Autologous connective tissue graft with rotated papilla flap; Device: Collagen matrix construct (Mucograft)

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
• Enrollment (Actual): 187
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • ICPDOI
• Germany
  • Hamburg, Germany
    • Praxis Dr. Halben
  • Munich, Germany
    • Praxis Prof Huerzeler - Dr Zuhr
  • Munich, Germany
    • Praxis Prof Wachtel - Dr Bolz
  • Munster, Germany
    • Praxis Prof. Topoll
• Greece
  • Athens, Greece
    • Clinic Fourmousis
• Italy
  • Florence, Italy
    • University of Florence
  • Piacenza, Italy
    • Practice Prof Giulio Rasperini
  • Pisa, Italy
    • University of Pisa
• Spain
  • Bilbao, Spain
    • Clinia Zabalegui
  • Malaga, Spain
    • Clinica Guerrero
• Switzerland
  • Langenthal, Switzerland
    • Praxis Wallkamm
  • Zurich, Switzerland
    • Praxis Burkhardt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Mucograft gingival augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recovery after surgery	Time to recover after surgery assessed by diary and post'op follow up professional assessment	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maurizio Tonetti
• Collaborators: 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)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: September 23, 2011
• First Posted (Estimate): September 26, 2011

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: gingival recession; collagen matrix; root coverage; periodontal surgery; mucograft; multiple exposed teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: ERGOPerio 11-01