Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

Conditions
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Sinus Floor Augmentation

Intervention / Treatment
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* Device: Bio-Oss
* Device: calcium phosphate ceramic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bio-Oss<br>the xenograft is of bovine origin where the organic phase has been eliminated. | Device: Bio-Oss<br>* It is a bone substitute of bovine origin<br>|
| Experimental: calcium phosphate ceramic<br>is a calcium phosphate biomaterial | Device: calcium phosphate ceramic<br>* It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of newly-formed bone | 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 | 6 months after surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density | This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing | at baseline and after 6 months of intervention | 
| Insertion torque | At the time of implant insertion and initial insertion torque will be registered | 6 months after surgical intervention | 
| Percentage of residual graft | The histological analysis will determine the percentage of residual graft after 6 months of surgery. | 6 months after surgical intervention | 
| Pain index | This will evaluate the intensity of pain the patient suffered due to the surgical intervention. | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention | 
| Healing index | This index will evaluate the soft tissue healing. | 7 days, 15 days and 1 month after surgical intervention | 
| Infection | Notify the infection of the graft material | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRGF-Endoret, Bone graft, Maxillary sinus, Vertical bone augmentation