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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178771
• Other study ID #: PRF effect on perio-parameters
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 25, 2022

Study information

• Verified date: September 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 25, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Iraq	Babylon University	Hilla	Babel

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical parameters	measurements of pocket depth in millimeter at baseline and at the end of study	4 weeks and 3 months
Secondary	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

External 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