Objectives The main objective of this study is to assess if the application of Emdogain in addition to coronally advanced flap is superior to coronally advanced flap alone in the treatment of multiple adjacent gingival recessions, in terms of professional evaluation of aesthetics, complete root coverage, and percentage of root coverage. Design and Outcomes This will be a parallel group, standard of care-controlled, randomized, multicenter, clinical trial. The statistical design will be a superiority trial in terms of the primary outcomes (professional outcomes measuring aesthetics and root coverage). Sample size has been estimated in 90 subjects per treatment arm using a pilot case series analyzed with a multilevel statistical approach and a superiority margin of 0.5 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 a practice-based research network in Italy. A single calibrated investigator, blind with respect to the treatment assignment, with specific experience in using the specific score, will centrally perform assessment of esthetic scores on standardized digital images. Trained personnel not involved with the surgical intervention will: i) administer patient questionnaires, ii) provide instructions and collect patient diaries. A biostatistician blind with respect to treatment assignment will perform the analysis.
Attenzione! Scheda prodotto non ancora validata dall'Ateneo
|Titolo:||Coronally Advanced Flap vs Coronally Advanced Flap plus Emdogain for Coverage of Multiple Gingival Recession Defects|
|Autori:||Tonetti, Maurizio; Cortellini, Pierpaolo; Bertoldi, Carlo|
|Data di pubblicazione:||2015|
|Appare nelle tipologie:||Partecipazione a progetti di ricerca|
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