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

Clin Oral Implants Res. 2019 Jun;30(6):487-497. doi: 10.1111/clr.13426. Epub 2019 May 14.


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.

Keywords: collagen membrane; dehisced implant sites; guided bone regeneration; randomized clinical trial; simultaneous implant placement.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Bone Regeneration
  • Collagen
  • Dental Implantation, Endosseous*
  • Esthetics, Dental
  • Follow-Up Studies
  • Humans
  • Membranes, Artificial
  • Quality of Life*
  • Treatment Outcome


  • Membranes, Artificial
  • Collagen