Clinical trial NCT01771302: Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
Official title: Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Augmentation
Keywords: PRGF-Endoret
Bone graft
Maxillary sinus
Vertical bone augmentation
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
Collaborators: name: Biotechnology Institute IMASD
First posted: 2013-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of newly-formed bone
timeFrame: 6 months after surgical intervention
Secondary outcomes:
measure: Bone density
timeFrame: at baseline and after 6 months of intervention
measure: Insertion torque
timeFrame: 6 months after surgical intervention
measure: Percentage of residual graft
timeFrame: 6 months after surgical intervention
measure: Pain index
timeFrame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
measure: Healing index
timeFrame: 7 days, 15 days and 1 month after surgical intervention
measure: Infection
timeFrame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clinica Eduardo Anitua
Study officials:
affiliation: Clinica Eduardo Anitua
name: Eduardo Anitua, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: