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

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Fundación Eduardo Anitua

Status

Completed

Conditions

Sinus Floor Augmentation

Treatments

Device: calcium phosphate ceramic
Device: Bio-Oss

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01771302
BTI-EC/12/Biomat

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

12 participants in 2 patient groups

Bio-Oss
Active Comparator group
Description:
the xenograft is of bovine origin where the organic phase has been eliminated.
Treatment:
Device: Bio-Oss
calcium phosphate ceramic
Experimental group
Description:
is a calcium phosphate biomaterial
Treatment:
Device: calcium phosphate ceramic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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