A blind randomized controlled pilot trial on recombinant human bone morphogenetic protein-2 in combination with a bioresorbable membrane on periodontal regeneration in mandibular molar furcation defects.

Objectives: In preparation of a definitive randomized clinical trial (RCT), the current parallel-grouped triple-blind pilot RCT assessed the efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) with polylactic acid/polyglycolic acid (PLA/PGA) membrane for improvement of periodontal tissue regeneration in Class II furcation type defects. Method and materials: With the present single-center investigation, 24 patients/24 mandibular molars revealing Class II furcation lesions with involved buccal surfaces were randomly allocated and treated surgically, using either a PLA/PGA membrane alone (control, n= 12) or in combination with rhBMP-2 (n= 12). Assessors, participants, and the statistician were blinded to the treatment groups. Clinical parameters including Plaque Index (PI), Papillary Bleeding Index (PBI), clinical attachment level, vertical probing depth, horizontal probing depth, and gingival recession were assessed at baseline and 6 months postsurgery. Results: Baseline values concerning the investigated parameters were comparable between both groups (P >. 05). After 6 months, clinical attachment level gain was similar (P=. 76), while greater reductions in vertical probing depth (P=. 01) and horizontal probing depth (P=. 05), along with less gingival recession (P=. 03) were observed in the PLA/PGA+ rhBMP-2 group (compared to the controls). An increased number of completely closed furcation type defects was observed in the PLA/PGA+ rhBMP-2 group (with no adverse effects). Conclusions: When treating Class II furcation lesions, the use of rhBMP-2 (combined with PLA/PGA membranes) seems advantageous. The presented set-up seems feasible with regards to recruitment, randomization, acceptance, retention, and adherence to the study protocol.