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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Fundación Eduardo Anitua.
Recruitment status was:  Recruiting
Biotechnology Institute IMASD
Information provided by (Responsible Party):
Fundación Eduardo Anitua Identifier:
First received: January 15, 2013
Last updated: January 23, 2013
Last verified: January 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 Intervention
Sinus Floor Augmentation Device: Bio-Oss Device: calcium phosphate ceramic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

Resource links provided by NLM:

Further study details as provided by Fundación Eduardo Anitua:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 12
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01771302

Clinica Eduardo Anitua Recruiting
Vitoria, Spain
Contact: Virginia Caudrado    +34945160653   
Sponsors and Collaborators
Fundación Eduardo Anitua
Biotechnology Institute IMASD
Principal Investigator: Eduardo Anitua, MD, DDS, PhD Clinica Eduardo Anitua
  More Information

Responsible Party: Fundación Eduardo Anitua Identifier: NCT01771302     History of Changes
Other Study ID Numbers: BTI-EC/12/Biomat
Study First Received: January 15, 2013
Last Updated: January 23, 2013

Keywords provided by Fundación Eduardo Anitua:
Bone graft
Maxillary sinus
Vertical bone augmentation

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 21, 2017