UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT07584629
split-mouth RCT. 12 patients. horizontal GBR performed. 2 grafts were compared: test was LPRF block, control was 50% autogenous bone and 50% DBBM. 25 months follow-up.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
12 patients were included in this split-mouth RCT. In test sites a horizontal GBR procedure was performed using a collagen membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In control sites a collagen 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
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
Other names: GBR, Implant placement after bone healing
Time frame: at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
bone volume is measured on CBCT scans of the jaw
Time frame: measured at placement of the implant and 1 year later
thickness of the buccal bone plate of the oral implant
Time frame: measured at the 1 year loading follow-up
survival of the implants over the follow-up time
Time frame: from the gbr surgery to 25 months follow-up
all possible complications were registered and monitored
Universitaire Ziekenhuizen KU Leuven
Other
Horizontal 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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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