Plasma Rich in Growth Factors in Post-extraction Sockets
Clinical Behavior and Molecular Pathways of PRGF in Post-extraction Sockets
1 other identifier
interventional
30
1 country
1
Brief 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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2019
CompletedFirst Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMarch 30, 2025
March 1, 2025
5.7 years
May 7, 2019
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
PRGF
EXPERIMENTALPost-extraction socket grafted with PRGF-Endoret
ABB
ACTIVE COMPARATORPost-extraction socket grafted with anorganic bovine bone (ABB)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de Granadalead
- BTI Biotechnology Institutecollaborator
Study Sites (1)
Facultad de Odontología
Granada, Granada, 18071, Spain
Related 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.
PMID: 24998770BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Galindo-Moreno, DDS, PhD
Universidad de Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
March 4, 2019
Primary Completion
November 18, 2024
Study Completion
July 1, 2025
Last Updated
March 30, 2025
Record last verified: 2025-03