Allogeneic bone paste versus bone powder for oral guided bone regeneration: A randomized, noninferiority trial
Bruno Courtois1, Arnaud L'Homme1, Marie-Pierre Labadie1
1Centre de Chirurgie Orale et Implantologie, Toulouse, France.
Background:
There is demand for new biomaterials that reduce the morbidity associated with a second graft site needed for autologous bone grafting and facilitate the surgical procedure. Here we compared bone volume gain using a supercritical CO2-processed allogeneic bone paste and bone powder in partially edentulous patients requiring bone augmentation of alveolar ridges by guided bone regeneration (GBR) to place one or more implants.
Methods:
Eighty-six patients with bone defects requiring horizontal and/or vertical bone augmentation were randomly assigned to receive allogeneic bone paste or bone powder for GBR. The primary outcome was horizontal bone gain at implant placement measured by cone-beam computed tomography (CBCT) 4-6 months post grafting. Secondary outcomes were ease of graft manipulation, surgery duration, absolute bone gain, peri-implant marginal bone height, implant survival, and complications.
Results:
Of 42 bone paste patients receiving 51 implants and 40 bone powder patients receiving 53 implants analyzed per protocol, 38% and 72% achieved horizontal bone gain corresponding to the desired pregraft bone volume, respectively (p < 0.001). Both groups showed stable bone gain during initial healing and after implant placement, with 88.6% and 90.6% of implants maintained in the bone paste and bone powder groups at study completion, respectively (p = 0.43). Six implants were lost in the bone paste group and five in the bone powder group.
Conclusions:
Supercritical CO2-processed bone paste allografts are safe, augment bone, and result in acceptable implant survival for alveolar ridge augmentation by GBR. However, suboptimal material properties due to the viscoelastic consistency of the bone paste resulted in significantly less bone gain than bone powder, which will guide the choice of material clinically.
Clinical Trial Registration:
The trial is registered at the US National Library ClinicalTrials.gov (NCT04141215).
Plain Language Summary:
This first randomized controlled trial of supercritical CO2-processed bone paste allografts confirms their safety, adequate bone augmentation, and implant survival, but inadequate mechanical strength resulted in significantly less bone gain than with bone powder.
