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

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Fundación Eduardo Anitua

Status

Completed

Conditions

Post-Extraction Sockets Healing

Treatments

Biological: Plasma Rich in Growth Factors PRGF-Endoret
Procedure: Conventional closure of the lesion

Study type

Interventional

Funder types

Other

Identifiers

NCT01465399
FIBEA-01-EC/11/ALV
2019-001167-75 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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