Plasma Rich in Growth Factors in Post-extraction Sockets

Dental Implants Clinical Trial

Official title:

Clinical Behavior and Molecular Pathways of PRGF in Post-extraction Sockets

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03943680
• Other study ID #: 1962-N-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical success, radiographical volume maintenance and histological bone regeneration after using either a bovine bone xenograft or an autogenous platelet rich plasma enrich in growth factors, known as Endoret®-PRGF®.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Upper or lower premolar or molar tooth in need of extraction and later restoration by dental implant.
• Adjacent and opposing natural teeth present and healthy.
• At least 3 mm from the tip of the dental root to the maxillary sinus or the inferior alveolar canal.

Exclusion Criteria:

• Active local infection.
• Uncontrolled diabetes mellitus.
• Long term (>10 years) use of oral bisphosphonates.
• Use of intravenous bisphosphonates.
• Recent use (<3 months) of antibiotics, antiinflammatories or analgesics drugs.
• Pregnancy.
• Smokers of more than 10 cigarettes per day.
• Any oral pathology that needs to be treated before tooth extraction, particularly the presence of more than 25% of sites with bleeding on probing.

Related Conditions & MeSH terms

• Dental Implants
• Tooth Extraction

Intervention

Device:
• PRGF
After tooth extraction, the socket will be grafted with PRGF-Endoret
• ABB
After tooth extraction, the socket will be grafted with Geistlich Bio-Oss® Collagen

Locations

Country	Name	City	State
Spain	Facultad de Odontología	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	BTI Biotechnology Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Anitua E, Murias-Freijo A, Alkhraisat MH, Orive G. Clinical, radiographical, and histological outcomes of plasma rich in growth factors in extraction socket: a randomized controlled clinical trial. Clin Oral Investig. 2015 Apr;19(3):589-600. doi: 10.1007/s00784-014-1278-2. Epub 2014 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar bone change in Cone Beam Computerized Tomography	Volumetric change in the alveolar bone from immediately after tooth extraction to immediately before implant placement (4 months after the extraction and grafting of the socket)	Baseline and 4 months