Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets

NCT ID: NCT01465399

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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Immediately following tooth removal, a healing process begins that affects the eventual alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring expensive and time-consuming reconstructive surgeries, or even the inability to be corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect to minimize the consequences of this aggression, promoting the regeneration of both hard and soft involved tissues.

Detailed Description

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Conditions

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Post-Extraction Sockets Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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PRGF-Endoret

Group Type EXPERIMENTAL

Plasma Rich in Growth Factors PRGF-Endoret

Intervention Type BIOLOGICAL

Conventional treatment

Group Type ACTIVE_COMPARATOR

Conventional closure of the lesion

Intervention Type PROCEDURE

Interventions

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Plasma Rich in Growth Factors PRGF-Endoret

Intervention Type BIOLOGICAL

Conventional closure of the lesion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subjects of both genders and ≥ 18 years old
* Indication of a simple one molar extraction in the mandible.
* Possibility of observation during the follow-up period.

Exclusion Criteria

* Unerupted third molars or with horizontal inclination.
* Severe swelling prior to surgery in the areas designated for extraction.
* Suffering an alteration or a serious hematologic disease.
* Be currently undergoing or have received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and/or anticoagulants 30 days prior to inclusion
* In regular treatment with NSAIDs or other anti-inflammatory drugs.
* History of chronic hepatitis or cirrhosis.
* Diabetes mellitus with poor metabolic control (glycosylated hemoglobin \>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 planned pregnancy during the study follow-up period.
* Metabolic Bone Disease.
* Patients taking bisphosphonates both orally and intravenously.
* In general, any inability to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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: STUDY_DIRECTOR

Clinica Dental Eduardo Anitua

Locations

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Clínica Dental Eduardo Anitua

Vitoria-Gasteiz, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2019-001167-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FIBEA-01-EC/11/ALV

Identifier Type: -

Identifier Source: org_study_id

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