- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506252
Influence of Hydration Status on the Yield of Injectable Platelet-Rich Fibrin (T-PRF)
Influence of the Drinking Amount on the Autologous Blood in the Centrifuge Contained Fibrin Matrix - Platelet-rich Fibrin A Randomized Controlled Pilot Study
Due to the current lack of evidence regarding the influence of fluid intake on the amount of leukocyte- and platelet-rich fibrin fraction present in blood samples, this study aims to investigate the positive influence of this factor on the body's own matrix.
Platelet-rich fibrin, a fibrin-rich autologous matrix obtained from autologous blood via centrifugation, contains not only fibrin but also important growth factors and a large number of white blood cells, all of which make a significant contribution to tissue regeneration. The obtained fibrin matrix can be used as a membrane, as a clot (A-PRF), or as a liquid (i-PRF) to positively influence the healing process.
The novelty of this work lies in shifting the focus from purely technical centrifugation parameters to a patient-centered, easily modifiable biological variable. Hydration status represents a low-cost, non-invasive, and immediately applicable strategy to optimize autologous blood concentrates. These findings are directly relevant to clinicians seeking to enhance the predictability and efficiency of PRF-based regenerative procedures in implant dentistry.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- Medical University of Graz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- coagulation disorders
- anticoagulant medication
- pregnancy
- acute infections
- systemic diseases with the potential to affect wound healing or blood composition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hydration
Drinking protocol to reach euhydration
|
Participants followed a drinking protocol the day before the measurement to reach euhydration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRF-Volume
Time Frame: 3 visits, 3 weeks
|
Volume (ml) of i-PRF obtained from each 10 ml blood sample with low speed centrifugation
|
3 visits, 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRF yield and height
Time Frame: 3 visits, 3 weeks
|
Correlation of PRF yield in ml and height in cm
|
3 visits, 3 weeks
|
|
PRF yield and weight
Time Frame: 3 visits, 3 weeks
|
Correlation of PRF yield in ml and weight in kg
|
3 visits, 3 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.
- Verboket RD, Anbar B, Sohling N, Kontradowitz K, Marzi I, Ghanaati S, Henrich D. Changes in platelet-rich fibrin composition after trauma and surgical intervention. Platelets. 2020 Nov 16;31(8):1069-1079. doi: 10.1080/09537104.2020.1714575. Epub 2020 Jan 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 34-508 ex 21/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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