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. Issue 6 (14th May 2019)

• Record Type: Journal Article
• Authors: Urban, Istvan A.; Wessing, Bastian; Alández, Nuria; Meloni, Silvio; González‐Martin, Oscar; Polizzi, Giovanni; Sanz‐Sanchez, Igancio; Montero, Eduardo; Zechner, Werner
• Is Part Of: Clinical oral implants research. Volume 30:Issue 6(2019)
• Page Start: 487
• Page End: 497
• Publication Date: 2019-05-14
• Subjects: collagen membrane -- dehisced implant sites -- guided bone regeneration -- randomized clinical trial -- simultaneous implant placement; Dental implants -- Research -- Periodicals; 617.69
• DOI: 10.1111/clr.13426
• Languages: English
• ISSNs: 0905-7161

Abstract

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.