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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02692079
Other study ID # 2014/18
Secondary ID
Status Completed
Phase N/A
First received February 18, 2016
Last updated February 22, 2016
Start date February 2014
Est. completion date November 2014

Study information

Verified date February 2016
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 26 Years to 59 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Procedure:
T-PRF
Flap Surgery
Allograft
Flap Surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Within the first 30 days after surgery No
Secondary The Volume of Gingival Crevicular Fluid (microliter) Within the first 30 days after surgery No
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