A multicenter randomized controlled trial using a novel collagen membrane for guided bone regeneration at dehisced single implant sites: Outcome at prosthetic delivery and at 1‐year follow‐up

Abstract Objectives To compare clinical performance of a novel resorbable non‐cross‐linked collagen membrane (CXP) with a reference membrane (non‐cross‐linked resorbable membrane; BG) for simultaneous implant placement and guided bone regeneration (GBR) at dehisced single implant sites. Materials and methods Preliminary data from this randomized controlled trial were reported previously; this is the 12‐month report. The primary outcome measure was defected height at 6 months post‐GBR. Secondary outcomes included implant cumulative survival rate (CSR) and success rate since placement; bone level changes, pink esthetic score (PES), and patient satisfaction since definitive prosthesis delivery; patient quality of life since pretreatment; and the 1‐year bleeding index. Non‐parametric statistical analyses were performed. Results Among patients, 24 were treated with CXP and 25 with BG. The 1‐year implant CSR and success rate were 100% ( n = 42). Bone level change between definitive prosthetic delivery and 1 year was not significantly different between the CXP and BG groups (BG + 0.42 mm, CXP + 0.01 mm). The PES increased from 7.55 to 8.10 for the CXP group and from 6.48 to 7.48 for the BG group; 1‐year bleeding indices were 0 (16 CXP, 18 BG) and 1 (4 CXP, 2 BG). Patient quality of life changed from an OHIP‐14 score of 6.5 at pretreatment to 1.9 at 1 year. Overall satisfaction (visual analogue score) with function and esthetics was 9.9 and 9.7, respectively. Inter‐group differences were not significant for assessed outcomes. No device‐related adverse events were reported. Conclusions The use of CXP and BG for simultaneous implant placement and GBR at dehisced implant sites similarly reduced defect height and improved secondary measures, indicating non‐inferiority.