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

The Efficacy of Application of Platelet-rich Fibrin on Periodontal Clinical Parameters and Gingival Crevicular Fluid Platelet-derived Growth Factor-BB and Periostin Levels

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Other: Platelet rich fibrin

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Babel
    • Hilla, Babel, Iraq, 51001
      • Babylon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test site; The test site will receive ScRp in addition to PRF	Other: Platelet rich fibrin; 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.
No Intervention: control sites; The control site will be treated by ScRp only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical parameters	measurements of pocket depth in millimeter at baseline and at the end of study	4 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks and 3 months

Collaborators and Investigators

• Sponsor: University of Baghdad

Publications and helpful links

Helpful Links

• Several potential benefits have been attributed to the platelet-rich fibrin (PRF), including enhanced tissue healing properties. The application of PRF as an adjunct to conventional scaling and root planing

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): September 25, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: PRF; PDGF-BB; Periostin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: PRF effect on perio-parameters

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