Sinus Floor Augmentation
Conditions
Brief summary
The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties. A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Interventions
DEVICENon-coated HA/TCP particles
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
DEVICEPLGA-coated HA/TCP particles
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating
Sponsors
University of Valencia
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Partially edentulous patients. * Kennedy class I or II in the upper jaw, from first premolar to second molar. * Less than 5 mm of residual crestal bone. * Need for the replacement of teeth with dental implants.
Exclusion criteria
* Sinus pathology (sinusitis, mucocele, cysts). * Smokers. * Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinus floor height change | 6 months | CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of new mineralized tissue | 6 months | Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure |
| Area of non-mineralized tissue | 6 months | Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure |
| Area of remaining graft particles | 6 months | Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure |
Countries
Spain
Outcome results
None listed