Clinical trial NCT01440426: Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: gingival recession
root coverage
periodontal surgery
collagen matrix
mucograft
multiple exposed teeth
Lead sponsor: The European Research Group on Periodontology (ERGOPerio)
Sponsor class: NETWORK
Collaborators: name: The European Research Group on Periodontology (ERGOPerio)
First posted: 2011-09-26
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Time to recovery after surgery
timeFrame: 3 months
Secondary outcomes:
measure: Complete root coverage
timeFrame: 6 months
measure: Percentage of root coverage
timeFrame: 6 months
measure: Esthetics
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ICPDOI
city: Hamburg
country: Germany
facility: Praxis Dr. Halben
city: Munich
country: Germany
facility: Praxis Prof Huerzeler - Dr Zuhr
city: Munich
country: Germany
facility: Praxis Prof Wachtel - Dr Bolz
city: Munster
country: Germany
facility: Praxis Prof. Topoll
city: Athens
country: Greece
facility: Clinic Fourmousis
city: Florence
country: Italy
facility: University of FLorence
city: Piacenza
country: Italy
facility: Practice Prof Giulio Rasperini
city: Pisa
country: Italy
facility: University of Pisa
city: Bilbao
country: Spain
facility: Clinia Zabalegui
city: Malaga
country: Spain
facility: Clinica Guerrero
city: Langenthal
country: Switzerland
facility: Praxis Wallkamm
city: Zurich
country: Switzerland
facility: Praxis Burkhardt
Study officials:
affiliation: The European Research Group on Periodontology (ERGOPerio)
name: Maurizio Tonetti, DMD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The European Research Group on Periodontology (ERGOPerio)
name: Pierpaolo COrtellini, MD
role: PRINCIPAL_INVESTIGATOR
References: