Trials / Completed
CompletedNCT06317090
Vertical GBR LPRF Block vs. Autogenous Bone With DBBM
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | guided bone regeneration | a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft. |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2024-03-19
- Last updated
- 2024-03-19
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT06317090. Inclusion in this directory is not an endorsement.