Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
NCT ID: NCT01771302
Last Updated: 2021-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2013-01-31
2014-04-30
Brief Summary
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The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bio-Oss
the xenograft is of bovine origin where the organic phase has been eliminated.
Bio-Oss
It is a bone substitute of bovine origin
calcium phosphate ceramic
is a calcium phosphate biomaterial
calcium phosphate ceramic
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
Interventions
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Bio-Oss
It is a bone substitute of bovine origin
calcium phosphate ceramic
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Biotechnology Institute IMASD
INDUSTRY
Fundación Eduardo Anitua
OTHER
Responsible Party
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Principal Investigators
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Eduardo Anitua, MD, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinica Eduardo Anitua
Locations
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Clinica Eduardo Anitua
Vitoria-Gasteiz, , Spain
Countries
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Other Identifiers
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BTI-EC/12/Biomat
Identifier Type: -
Identifier Source: org_study_id
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