Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
|ClinicalTrials.gov Identifier: NCT01771302|
Recruitment Status : Unknown
Verified January 2013 by Fundación Eduardo Anitua.
Recruitment status was: Recruiting
First Posted : January 18, 2013
Last Update Posted : January 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sinus Floor Augmentation||Device: Bio-Oss Device: calcium phosphate ceramic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||January 2015|
Active Comparator: Bio-Oss
the xenograft is of bovine origin where the organic phase has been eliminated.
It is a bone substitute of bovine origin
Experimental: calcium phosphate ceramic
is a calcium phosphate biomaterial
Device: calcium phosphate ceramic
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 [ Time Frame: 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
- Bone density [ Time Frame: 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 [ Time Frame: 6 months after surgical intervention ]At the time of implant insertion and initial insertion torque will be registered
- Percentage of residual graft [ Time Frame: 6 months after surgical intervention ]The histological analysis will determine the percentage of residual graft after 6 months of surgery.
- Pain [ Time Frame: 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.
- Healing index [ Time Frame: 7 days, 15 days and 1 month after surgical intervention ]This index will evaluate the soft tissue healing.
- Infection [ Time Frame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention ]Notify the infection of the graft material
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771302
|Clinica Eduardo Anitua||Recruiting|
|Contact: Virginia Caudrado +34945160653 firstname.lastname@example.org|
|Principal Investigator:||Eduardo Anitua, MD, DDS, PhD||Clinica Eduardo Anitua|