Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects
Recruitment status was: Recruiting
|Gingival Recession||Procedure: Autologous connective tissue graft with rotated papilla flap Device: Collagen matrix construct (Mucograft)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- Time to recovery after surgery [ Time Frame: 3 months ]Time to recover after surgery assessed by diary and post'op follow up professional assessment
- Complete root coverage [ Time Frame: 6 months ]Frequency of complete root coverage
- Percentage of root coverage [ Time Frame: 6 months ]Percentage of the exposed tooth root covered after surgical intervention
- Esthetics [ Time Frame: 6 months ]Professional assessment by blind assessor of the esthetic result
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440426
|Contact: Gaia Pellegrini, DMDemail@example.com|
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|Principal Investigator: Patrick Adriaens, MD PhD|
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|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)|