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

Not Applicable

Completed

• Conditions: Sinus Floor Augmentation
• Interventions: Device: Bio-Oss; Device: calcium phosphate ceramic

• Registration Number: NCT01771302
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-Oss	Bio-Oss	the xenograft is of bovine origin where the organic phase has been eliminated.
calcium phosphate ceramic	calcium phosphate ceramic	is a calcium phosphate biomaterial

Primary Outcome Measures

Name	Time	Method
Percentage of newly-formed bone	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

Secondary Outcome Measures

Name	Time	Method
Pain index	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.
Bone density	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	6 months after surgical intervention	At the time of implant insertion and initial insertion torque will be registered
Percentage of residual graft	6 months after surgical intervention	The histological analysis will determine the percentage of residual graft after 6 months of surgery.
Infection	7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention	Notify the infection of the graft material
Healing index	7 days, 15 days and 1 month after surgical intervention	This index will evaluate the soft tissue healing.

Trial Locations

Locations (1)

Clinica Eduardo Anitua; 🇪🇸 Vitoria, Spain