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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Extraction Sockets Healing
• Intervention / Treatment: Biological: Plasma Rich in Growth Factors PRGF-Endoret; Procedure: Conventional closure of the lesion

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Vitoria, Spain
    • Clínica Dental Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of regenerated post-extraction sockets	10-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-12 weeks
Post-operative pain (VAS)		3, 7 and 15 days post-extraction
Soft Tissue Healing Index		3, 7 and 15 days post-extraction
Inflammation	Using a specific 0 to 3 Inflammation Score	3, 7 and 15 days post-extraction
Adverse events or complications		10-12 weeks

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Investigators: Study Director: Eduardo Anitua, MD, DDS, PhD, Clínica Dental Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: FIBEA-01-EC/11/ALV; 2019-001167-75 (EudraCT Number)