Alveolar Bone Resorption
Conditions
Brief 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.
Interventions
PROCEDUREguided bone regeneration
a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
neither the patient, nor the outcome assessor was aware at which side which grafting material was used
Intervention model description
split-mouth 2 arm RCT
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 as measured on CBCT scans | CBCT scans at intake, with follow-up until 25 months post-operative | CBCT scans taken and software used for measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Buccal bone thickness around the implants | CBCT scans at placement of the implant and 1 year after loading of the implant | Bone thickness measured on CBCT scans |
| Cumulative survival rate of the implants | 16 months of follow-up | Implants followed for 1 year after loading and survival recorded |
| rates and types of complications | 25 months | All complications recorded during 25 months follow-up |
Countries
Belgium
Outcome results
None listed