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 rhBM P-2 (n =12). Assessors, participants, and the statistician were blinded to the treatment groups. Clinical parameters including Plaque Index vertical probing depth, horizontal probing depth, and gingival recession were assessed at baseline and 6 months postsurgery.Results: Baseline values concerning the investigated param-eters 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 reces-sion (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 rh BM P-2 (combined with PLA/PGA membranes) seems advantageous. The presented set-up seems feasible with regards to recruitment, randomiza-tion, acceptance, retention, and adherenceto the study protocol. (Quintessence Int 2023;54:112-124; doi:10.3290/j.gi.b3631815)