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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bio-Oss

the xenograft is of bovine origin where the organic phase has been eliminated.

Group Type ACTIVE_COMPARATOR

Bio-Oss

Intervention Type DEVICE

It is a bone substitute of bovine origin

calcium phosphate ceramic

is a calcium phosphate biomaterial

Group Type EXPERIMENTAL

calcium phosphate ceramic

Intervention Type DEVICE

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

Intervention Type DEVICE

calcium phosphate ceramic

It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biotechnology Institute IMASD

INDUSTRY

Sponsor Role collaborator

Fundación Eduardo Anitua

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

Other Identifiers

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BTI-EC/12/Biomat

Identifier Type: -

Identifier Source: org_study_id

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