Alveolar Bone Resorption
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREguided bone regeneration
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
patient was not aware which side received which grafting material Outcome assessor was not awara which side received which grafting material.
Intervention model description
split-mouth RCT 2 arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females, with ASA I or II, between 18 and 80 years old * 2 implant sites requiring vertical bone augmentation prior to implant placement * Both sites in the same jaw * Good general health as documented by self-assessment
Exclusion criteria
* Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient * Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication. * Current pregnancy or breast feeding/ lactating at the time of recruitment. * Radiotherapy or Chemotherapy in head and neck area. * Intravenous and oral bisphosphonate therapy. * Smoking * Unwillingness to return for the follow-up examination. * Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations * Presence of osseous pathologies, that might interfere with normal wound healing * Presence of oral lesions (such as ulceration, malignancy) * Local inflammation, including untreated periodontitis * Patients with inadequate oral hygiene or unmotivated for adequate home care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone volume changes | at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative | bone volume is measured on CBCT scans of the jaw |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of complications | from the gbr surgery to 25 months follow-up | all possible complications were registered and monitored |
| Cumulative survival rate of the implants | measured at the 1 year loading follow-up | survival of the implants over the follow-up time |
| buccal bone thickness on CBCT scan | measured at placement of the implant and 1 year later | thickness of the buccal bone plate of the oral implant |
Countries
Belgium
Outcome results
None listed