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

Not Applicable

Completed

• Conditions: Post-Extraction Sockets Healing
• Interventions: Procedure: Conventional closure of the lesion; Biological: Plasma Rich in Growth Factors PRGF-Endoret

• Registration Number: NCT01465399
• Lead Sponsor: Fundación Eduardo Anitua

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Conventional closure of the lesion	-
PRGF-Endoret	Plasma Rich in Growth Factors PRGF-Endoret	-

Primary Outcome Measures

Name	Time	Method
Percentage of regenerated post-extraction sockets	10-12 weeks

Secondary Outcome Measures

Name	Time	Method
Soft Tissue Healing Index	3, 7 and 15 days post-extraction
Adverse events or complications	10-12 weeks
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
Inflammation	3, 7 and 15 days post-extraction	Using a specific 0 to 3 Inflammation Score

Trial Locations

Locations (1)

Clínica Dental Eduardo Anitua; 🇪🇸 Vitoria, Spain