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

NCT05178771 | Completed

• 1 other identifier: PRF effect on perio-parameters
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

PRF; PDGF-BB; Periostin

Outcome Measures

Primary Outcomes (1)

• clinical parameters

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

  4 weeks and 3 months

Secondary Outcomes (1)

• PDGF-BB and periostin level in GCF

  4 weeks and 3 months

Study Arms (2)

test site

EXPERIMENTAL

The test site will receive ScRp in addition to PRF

Other: Platelet rich fibrin

control sites

NO INTERVENTION

The control site will be treated by ScRp only

Interventions

Platelet rich fibrin 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.

test site

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients.
• Patients with periodontitis.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Babylon University

Hillah, Babel, 51001, Iraq

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be performed by coin toss method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: 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)

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: March 1, 2022
• Primary Completion: August 5, 2022
• Study Completion: September 25, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)