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

Fundación Eduardo Anitua12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sinus Floor Augmentation

Interventions

Bio-OssDEVICE

It is a bone substitute of bovine origin

calcium phosphate ceramicDEVICE

It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Outcomes

Primary Outcomes

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

Time frame: 6 months after surgical intervention

Secondary Outcomes

Bone density

This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing

Time frame: at baseline and after 6 months of intervention

Insertion torque

At the time of implant insertion and initial insertion torque will be registered

Time frame: 6 months after surgical intervention

Percentage of residual graft

The histological analysis will determine the percentage of residual graft after 6 months of surgery.

Time frame: 6 months after surgical intervention

Pain index

This will evaluate the intensity of pain the patient suffered due to the surgical intervention.

Time frame: 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.

Time frame: 7 days, 15 days and 1 month after surgical intervention

Infection

Notify the infection of the graft material

Time frame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention

Data from ClinicalTrials.gov

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