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

NCT01465399 — Not applicable, Completed, 60 participants, Fundación Eduardo Anitua

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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

Registry	NCT01465399
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, treatment
Enrollment	60 (Actual)
Sponsor	Fundación Eduardo Anitua (Other)
Conditions	Post-Extraction Sockets Healing
Interventions	Plasma Rich in Growth Factors PRGF-Endoret, Conventional closure of the lesion (Biological, procedure)
Dates	start 2011-10-01, primary completion 2012-12-01, completion 2012-12-01, first posted 2011-11-04, last updated 2021-08-23
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
PRGF-Endoret	Experimental	Biological: Plasma Rich in Growth Factors PRGF-Endoret
Conventional treatment	Active comparator	Procedure: Conventional closure of the lesion

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

+Outcome measures

Primary outcomes

Percentage of regenerated post-extraction sockets [10-12 weeks]

Secondary outcomes

Regenerated bone volume [10-12 weeks]: 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) [3, 7 and 15 days post-extraction]
Soft Tissue Healing Index [3, 7 and 15 days post-extraction]
Inflammation [3, 7 and 15 days post-extraction]: Using a specific 0 to 3 Inflammation Score
Adverse events or complications [10-12 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Clínica Dental Eduardo Anitua	Vitoria-Gasteiz	Spain

+Investigators

Eduardo Anitua, MD, DDS, PhD, Study director, Clinica Dental Eduardo Anitua

+Funding

NIH grants: 2019