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

NCT ID: NCT05178771

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-25

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

test site

The test site will receive ScRp in addition to PRF

Group Type: EXPERIMENTAL

Platelet rich fibrin

Intervention Type: OTHER

1. 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.

2. 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.

3. 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.

4. 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.

control sites

The control site will be treated by ScRp only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Platelet rich fibrin

1. 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.

2. 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.

3. 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.

4. 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Sarah Alrihaymee

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Babylon University

Hillah, Babel, Iraq

Countries

Iraq

Other Identifiers

PRF effect on perio-parameters

Identifier Type: -

Identifier Source: org_study_id