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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundación Eduardo Anitua
ClinicalTrials.gov Identifier:
NCT01465399
First received: October 27, 2011
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Post-Extraction Sockets Healing
Biological: Plasma Rich in Growth Factors PRGF-Endoret
Procedure: Conventional closure of the lesion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial, Controlled With Conventional Treatment, of Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-extraction Sockets in Simple Extractions of Molars in the Mandible

Further study details as provided by Fundación Eduardo Anitua:

Primary Outcome Measures:
  • Percentage of regenerated post-extraction sockets [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regenerated bone volume [ Designated as safety issue: No ]
    Measurement of the regenerated bone volume at final follow-up in relation to the initial post-extraction socket total volume measured by CT-Scanner and expressed as a percentage.

  • Post-operative pain (VAS) [ Designated as safety issue: No ]
  • Soft Tissue Healing Index [ Designated as safety issue: No ]
  • Inflammation [ Designated as safety issue: No ]
    Using a specific 0 to 3 Inflammation Score

  • Adverse events or complications [ Designated as safety issue: Yes ]

Study Start Date: June 2011
Arms Assigned Interventions
Experimental: PRGF-Endoret Biological: Plasma Rich in Growth Factors PRGF-Endoret
Active Comparator: Conventional treatment Procedure: Conventional closure of the lesion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01465399

Locations
Spain
Clínica Dental Eduardo Anitua
Vitoria, Spain
Sponsors and Collaborators
Fundación Eduardo Anitua
Investigators
Study Director: Eduardo Anitua, MD, DDS, PhD Clinica Dental Eduardo Anitua
  More Information

No publications provided

Responsible Party: Fundación Eduardo Anitua
ClinicalTrials.gov Identifier: NCT01465399     History of Changes
Other Study ID Numbers: FIBEA-01-EC/11/ALV
Study First Received: October 27, 2011
Last Updated: December 24, 2012
Health Authority: Spain: CEIC Hospital Santiago

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014