An interventional study of Bio-Oss and calcium phosphate ceramic in Sinus Floor Augmentation, sponsored by Fundación Eduardo Anitua. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Fundación Eduardo Anitua · Not applicable, Interventional, and Treatment
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.
Fundación Eduardo Anitua is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the xenograft is of bovine origin where the organic phase has been eliminated.
Device: Bio-Oss
is a calcium phosphate biomaterial
Device: calcium phosphate ceramic
It is a bone substitute of bovine origin
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
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
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Fundación Eduardo Anitua