RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari
About this trial
The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).
Eligibility criteria
Qualifiers
Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
Patents able to understand and sign an informed consent.
Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.
Disqualifiers
General contraindications to implant surgery.
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients.
Patients treated or under treatment with intravenous amino-bisphosphonates.
Trial design
Treatments tested in this trial
- A-oss and autogenous bone
- A-oss an LCR-A
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Università degli Studi di Sassari
Lead sponsor
Melodia, Dario, M.D.
Collaborator
Pisano, Milena, M.D.
Collaborator
Dr. Aurea Lumbau
Collaborator
Meloni, Silvio Mario, M.D.
Collaborator
Baldoni, Edoardo, M.D.
Collaborator
Source ClinicalTrials.gov