Sinus Floor Augmentation
Conditions
Keywords
PRGF-Endoret, Bone graft, Maxillary sinus, Vertical bone augmentation
Brief summary
This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation. The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
Interventions
DEVICEBio-Oss
It is a bone substitute of bovine origin
DEVICEcalcium phosphate ceramic
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
Sponsors
Biotechnology Institute IMASD
Fundación Eduardo Anitua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over 18 years * Patients requiring implant prostheses oral rehabilitation. * Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants
Exclusion criteria
* Not having complete the informed consent form. * Sinusitis. * Alcoholism. * Suffering severe haematological disorder or disease. * Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion. * In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs. * Background of chronic hepatitis or liver cirrhosis. * Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%) * Patients undergoing dialysis. * Presence of malignant tumors, hemangiomas or angiomas in the extraction area. * History of ischemic heart disease in the last year. * Pregnancy or intention to become pregnant during the study follow-up period. * Metabolic bone disease * Patients taking bisphosphonates drugs both orally and intravenously. * In general, any inability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of newly-formed bone | 6 months after surgical intervention | The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone density | at baseline and after 6 months of intervention | This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing |
| Insertion torque | 6 months after surgical intervention | At the time of implant insertion and initial insertion torque will be registered |
| Percentage of residual graft | 6 months after surgical intervention | The histological analysis will determine the percentage of residual graft after 6 months of surgery. |
| Healing index | 7 days, 15 days and 1 month after surgical intervention | This index will evaluate the soft tissue healing. |
| Infection | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention | Notify the infection of the graft material |
| Pain index | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention | This will evaluate the intensity of pain the patient suffered due to the surgical intervention. |
Countries
Spain
Outcome results
None listed