- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03943680
Plasma Rich in Growth Factors in Post-extraction Sockets
May 9, 2026 updated by: Pablo Galindo-Moreno, Universidad de Granada
Clinical Behavior and Molecular Pathways of PRGF in Post-extraction Sockets
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®.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Granada
-
Granada, Granada, Spain, 18071
- Facultad de Odontología
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRGF
Post-extraction socket grafted with PRGF-Endoret
|
After tooth extraction, the socket will be grafted with PRGF-Endoret
Other Names:
|
|
Active Comparator: ABB
Post-extraction socket grafted with anorganic bovine bone (ABB)
|
After tooth extraction, the socket will be grafted with Geistlich Bio-Oss® Collagen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar bone change in Cone Beam Computerized Tomography
Time Frame: Baseline and 4 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pablo Galindo-Moreno, DDS, PhD, Universidad de Granada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
November 18, 2024
Study Completion (Actual)
October 30, 2025
Study Registration Dates
First Submitted
May 7, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 9, 2019
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 9, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1962-N-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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