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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Connective Tissue Graft vs Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects Randomized Controlled Clinical Trial Assessing Superiority in Heal

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 Summary:

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 res
Sponsor: Maurizio Tonetti

Current Primary Outcome: Time to recovery after surgery [ Time Frame: 3 months ]

Time to recover after surgery assessed by diary and post'op follow up professional assessment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: The European Research Group on Periodontology (ERGOPerio)

Dates:
Date Received: September 22, 2011
Date Started: September 2011
Date Completion: June 2013
Last Updated: September 23, 2011
Last Verified: September 2011