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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Fundación Eduardo Anitua
Sponsor:
Collaborator:
Biotechnology Institute IMASD
Information provided by (Responsible Party):
Fundación Eduardo Anitua
ClinicalTrials.gov Identifier:
NCT01771302
First received: January 15, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    At the time of implant insertion and initial insertion torque will be registered

  • Percentage of residual graft [ Time Frame: 6 months after surgical intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771302

Locations
Spain
Clinica Eduardo Anitua Recruiting
Vitoria, Spain
Contact: Virginia Caudrado    +34945160653    virginia.cuadrado@bti-implant.es   
Sponsors and Collaborators
Fundación Eduardo Anitua
Biotechnology Institute IMASD
Investigators
Principal Investigator: Eduardo Anitua, MD, DDS, PhD Clinica Eduardo Anitua
  More Information

No publications provided

Responsible Party: Fundación Eduardo Anitua
ClinicalTrials.gov Identifier: NCT01771302     History of Changes
Other Study ID Numbers: BTI-EC/12/Biomat
Study First Received: January 15, 2013
Last Updated: January 23, 2013
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014