This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

Secondary Outcome Measures:
  • 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.

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

  • Adverse events or complications

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01465399

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

Responsible Party: Fundación Eduardo Anitua 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

Additional relevant MeSH terms:
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017