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

Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

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 Overview

• Status: Completed
• Conditions: Sinus Floor Augmentation
• Intervention / Treatment: Device: Bio-Oss; Device: calcium phosphate ceramic

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Vitoria, Spain
    • Clinica Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bio-Oss; the xenograft is of bovine origin where the organic phase has been eliminated.	Device: Bio-Oss; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months after surgical intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing	at baseline and after 6 months of intervention
Insertion torque	At the time of implant insertion and initial insertion torque will be registered	6 months after surgical intervention
Percentage of residual graft	The histological analysis will determine the percentage of residual graft after 6 months of surgery.	6 months after surgical intervention
Pain index	This will evaluate the intensity of pain the patient suffered due to the surgical intervention.	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.	7 days, 15 days and 1 month after surgical intervention
Infection	Notify the infection of the graft material	7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Collaborators: Biotechnology Institute IMASD
• Investigators: Principal Investigator: Eduardo Anitua, MD, DDS, PhD, Clinica Eduardo Anitua

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (ESTIMATE): January 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Bone graft; Maxillary sinus; Vertical bone augmentation; PRGF-Endoret
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: BTI-EC/12/Biomat