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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPRF block group | Experimental | LPRF block covered by collagen membrane |
|
| Compound graft group | Experimental | 50% autogenous bone with 50% DBBM covered by collagen membrane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guided bone regeneration | Procedure | Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone volume changes | bone volume is measured on CBCT scans of the jaw | at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| buccal bone thickness on CBCT scan | thickness of the buccal bone plate of the oral implant | measured at placement of the implant and 1 year later |
| Cumulative survival rate of the implants | survival of the implants over the follow-up time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
all info available on request
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split-mouth RCT 2 arm
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patient was not aware which side received which grafting material Outcome assessor was not awara which side received which grafting material.
|
| measured at the 1 year loading follow-up |
| Rates of complications | all possible complications were registered and monitored | from the gbr surgery to 25 months follow-up |