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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465399
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):
Fundación Eduardo Anitua

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Extraction Sockets Healing Biological: Plasma Rich in Growth Factors PRGF-Endoret Procedure: Conventional closure of the lesion Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
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
Study Start Date : June 2011

Arm Intervention/treatment
Experimental: PRGF-Endoret Biological: Plasma Rich in Growth Factors PRGF-Endoret
Active Comparator: Conventional treatment Procedure: Conventional closure of the lesion

Primary Outcome Measures :
  1. Percentage of regenerated post-extraction sockets

Secondary Outcome Measures :
  1. Regenerated bone volume
    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.

  2. Post-operative pain (VAS)
  3. Soft Tissue Healing Index
  4. Inflammation
    Using a specific 0 to 3 Inflammation Score

  5. Adverse events or complications

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465399

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

Responsible Party: Fundación Eduardo Anitua Identifier: NCT01465399     History of Changes
Other Study ID Numbers: FIBEA-01-EC/11/ALV
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012

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