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Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Platelet rich fibrin
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring PRF, PDGF-BB, Periostin

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients.
  • Patients with periodontitis.

Exclusion Criteria:

  1. Medical history of systemic disease: diabetes, pregnancy, or lactation.
  2. Previous periodontal treatment for the last 6 months
  3. Grade II mobility
  4. Smoker or alcoholic patient.
  5. Teeth with untreated caries, endodontic lesions
  6. Symptoms of recent acute illness e.g., COVID-19 will be excluded as well

Sites / Locations

  • Babylon University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

test site

control sites

Arm Description

The test site will receive ScRp in addition to PRF

The control site will be treated by ScRp only

Outcomes

Primary Outcome Measures

clinical parameters
measurements of pocket depth in millimeter at baseline and at the end of study

Secondary Outcome Measures

PDGF-BB and periostin level in GCF
Measurement of PDGF-BB and periostin level in GCF in baseline data and at the end of study

Full Information

First Posted
December 16, 2021
Last Updated
September 28, 2022
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05178771
Brief Title
Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels
Official Title
The Efficacy of Application of Platelet-rich Fibrin on Periodontal Clinical Parameters and Gingival Crevicular Fluid Platelet-derived Growth Factor-BB and Periostin Levels
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Determine the efficacy of the non-invasive application of PRF on periodontal clinical parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival crevicular fluid.
Detailed Description
The adjunctive use of PRF with conventional ScRp may improve clinical healing, decrease tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment time. Since PRF can be utilized as a safe, natural method to repair tissues at a low cost. Our aim is to evaluate the effectiveness of the non-invasive application of PRF as an adjunct to ScRp in patients with stage III grade B periodontitis through measurements of gingival crevicular fluid levels of PDGF-BB and Periostin before and after treatment and compare it with ScRp alone. A split-mouth procedure will be performed to reduce confounders as possible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
PRF, PDGF-BB, Periostin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A split-mouth procedure will be formed. Two quadrants in each participant will be selected; the sites will be divided into two groups: control site( will treat by ScRp only) and test sites( will treat by ScRp and PRF)
Masking
ParticipantInvestigator
Masking Description
Randomization will be performed by coin toss method
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test site
Arm Type
Experimental
Arm Description
The test site will receive ScRp in addition to PRF
Arm Title
control sites
Arm Type
No Intervention
Arm Description
The control site will be treated by ScRp only
Intervention Type
Other
Intervention Name(s)
Platelet rich fibrin
Intervention Description
Intravenous blood (obtained by venipuncture of the antecubital vein) will be collected in two 10-mL sterile tubes without any anticoagulants and will be immediately centrifuged at 3,000 revolutions (400 × g) per minute for 10 minutes. A structured fibrin clot in the middle of the tube, just between the red corpuscles (RBCs) at the bottom and the acellular plasma at the top, will be separated from the RBCs using sterile tweezers and scissors and transferred on a sterile PRF box. The PRF will be then brought to a thickness of 1 mm by gently compressing in PRF box. Standardized PRF pieces will be obtained by measuring by a periodontal probe and cutting into 3 × 5 mm dimensions. The PRF pieces will be inserted into the periodontal pockets by filling the pockets from the base up to the gingival margin. A modified gingivectomy knife, of which the tip is made blunt, will be used. The PRF volume will be calculated by recording how many pieces will be inserted.
Primary Outcome Measure Information:
Title
clinical parameters
Description
measurements of pocket depth in millimeter at baseline and at the end of study
Time Frame
4 weeks and 3 months
Secondary Outcome Measure Information:
Title
PDGF-BB and periostin level in GCF
Description
Measurement of PDGF-BB and periostin level in GCF in baseline data and at the end of study
Time Frame
4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients. Patients with periodontitis. Exclusion Criteria: Medical history of systemic disease: diabetes, pregnancy, or lactation. Previous periodontal treatment for the last 6 months Grade II mobility Smoker or alcoholic patient. Teeth with untreated caries, endodontic lesions Symptoms of recent acute illness e.g., COVID-19 will be excluded as well
Facility Information:
Facility Name
Babylon University
City
Hilla
State/Province
Babel
ZIP/Postal Code
51001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels

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