The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid (T-PRF)
February 22, 2016 updated by: Meltem Karsiyaka Hendek, Kırıkkale University
The Effect of Titanium-Prepared Platelet-Rich Fibrin (T-PRF) Treatment on the Angiogenic Biomarkers in Gingival Crevicular Fluid (GCF) in Infrabony Defects of Patients With Chronic Periodontitis: A Randomized Controlled Clinical Trial
This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis.
In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals.
Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
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
26 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical Diagnosis of Chronic Periodontitis
- The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy
Exclusion Criteria:
- Systemic illnesses
- Any medications known to affect the outcomes of periodontal surgery
- Pregnancy and lactation
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: T-PRF+Allograft
The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets.
All sites were washed with sterile salin solution and bleeding control was performed.
Test group sites were treated with T-PRF+allograft
|
Flap Surgery
Flap Surgery
|
|
Experimental: Allograft
The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets.
All sites were washed with sterile salin solution and bleeding control was performed.
Control group sites were treated with only allograft
|
Flap Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)
Time Frame: Within the first 30 days after surgery
|
Within the first 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Volume of Gingival Crevicular Fluid (microliter)
Time Frame: Within the first 30 days after surgery
|
Within the first 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
February 22, 2016
First Posted (Estimate)
February 25, 2016
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.