UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT06317090
split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.
Other names: GBR
Time frame: CBCT scans at intake, with follow-up until 25 months post-operative
CBCT scans taken and software used for measurement
Time frame: CBCT scans at placement of the implant and 1 year after loading of the implant
Bone thickness measured on CBCT scans
Time frame: CBCT scans at 1 year after loading of the implant
Bone thickness measured on CBCT scans
Time frame: 16 months of follow-up
Implants followed for 1 year after loading and survival recorded
Time frame: 25 months
All complications recorded during 25 months follow-up
Universitaire Ziekenhuizen KU Leuven
Other
Vertical Guided Bone Regeneration: LPRF Block vs a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up
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