## Protocol Section
### Identification Module
**NCT ID:** NCT02692079

**Acronym:** T-PRF

**Brief Title:** The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid

**Official Title:** 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

#### Organization Study ID Info
**ID:** 2014/18
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-02-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-02-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Start Date
**Date:** 2014-02

**Status Verified Date:** 2016-02

#### Study First Post Date
**Date:** 2016-02-25
**Type:** ESTIMATED
**Study First Submit Date:** 2016-02-18
**Study First Submit QC Date:** 2016-02-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kırıkkale University

#### Responsible Party

**Investigator Affiliation:** Kırıkkale University

**Investigator Full Name:** Meltem Karsiyaka Hendek

**Investigator Title:** Corresponding author, Clinical Research

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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).

**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.

### Conditions Module

**Conditions:**

- Chronic Periodontitis

- Intrabony Periodontal Defect

**Keywords:**

- Angiogenesis

- Bilateral infrabony defect

- Flap surgery

- Titanium-prepared, platelet-rich ﬁbrin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: T-PRF

- Procedure: Allograft

**Label:** T-PRF+Allograft

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Procedure: Allograft

**Label:** Allograft

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- T-PRF+Allograft

**Description:** Flap Surgery

**Name:** T-PRF

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Allograft

- T-PRF+Allograft

**Description:** Flap Surgery

**Name:** Allograft

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

#### Secondary Outcomes

**Measure:** The Volume of Gingival Crevicular Fluid (microliter)

**Time Frame:** Within the first 30 days after surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 59 Years

**Minimum Age:** 26 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M28044

- Name: Chronic Periodontitis

- Relevance: HIGH

- As Found: Chronic Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000055113

- Term: Chronic Periodontitis

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
