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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post-Extraction Sockets Healing

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |