PRF Therapy for Pocket Reduction

Comparative Evaluation of Clinical Parameters in Early-Stage III Grade A Periodontitis Patients After Insertion of Platelet Rich Fibrin as Step 2 Phase I Therapy in Periodontal Pockets: A Randomized Clinical Trial

Periodontal regenerative therapy has focused on various non-surgical and surgical treatment methods. Platelet-rich fibrin (PRF) has shown to possess multiple uses, including properties that promote healing of both soft and hard tissues. In the present study, we hypothesized that the addition of PRF into periodontal pockets, as an adjunct to conventional scaling and root planing (SRP), would enhance the outcomes of non-surgical periodontal therapy. This split-mouth randomized controlled clinical trial included 26 periodontal pocket sites in 13 patients with periodontitis. The pockets were randomly assigned as either test or control sites. In the test group, PRF was placed as an adjunct to SRP, while the control group received SRP alone. Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured at baseline and at six weeks. The wound healing index was measured during the six-week follow-up period.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket
• Intervention / Treatment: Procedure: SRP and concomitant insertion of PRF membrane; Procedure: SRP

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80123
    • University of Naples Federico II
  • Napoli, Italy, 80131
    • Università Degli Studi Di Napoli Federico Ii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• either gender,
• aged 18 years or older,
• patients without a medical history of systemic diseases,
• patient with chronic periodontitis
• patient with 5 or 6 mm of probing depth

Exclusion Criteria:

• patients with medical history of systemic disease or bleeding disorders
• presence of other gingival diseases (such as leukoplakia, lichen planus, pemphigoid disorders, pemphigus vulgaris, herpetic lesions, Necrotizing Ulcerative Periodontitis (NUP)
• pregnancy
• history of any drug usage affecting the periodontium for the past six months (such as systemic antibiotic therapy)
• previous periodontal treatment in the last six months
• smoking
• teeth with untreated caries
• endodontic lesions and grade II or more mobility
• subjects with acute exacerbation of periodontitis
• patients with systemic
• disease or condition that could affect tissue healing (e.g., autoimmune disease)
• severe furcation involvement (grade II and III)
• abutment for prosthetic rehabilitation
• active orthodontic therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients treated with SRP and insertion of PRF	Procedure: SRP and concomitant insertion of PRF membrane; The pockets were treated with scaling and root planing (SRP) along with the simultaneous insertion of a Platelet Rich Fibrin (PRF) membrane. Blood samples were drawn without anticoagulants in 10 mL tubes, which were immediately centrifuged at 4000 rpm for 8 minutes. Upon centrifugation, the blood showed three distinct layers: the uppermost layer contained platelet poor plasma, the middle layer consisted of a fibrin clot, and the lowermost band appeared bright red due to the presence of red blood cells. The fibrin clot polymerized in a diffuse manner within the tube, which was then cut with sharp scissors and squeezed between two glass slides to obtain a thick membrane. The PRF membrane was carefully handled using a carrier and isolated with a periodontal pack dressing (Coe-Pak). All patients were followed up at one week and six weeks after the treatment.
Active Comparator: patients treated with SRP	Procedure: SRP; The pockets were treated using the conventional procedure of scaling and root planing (SRP) utilizing curettes and an ultrasonic device. All patients were followed up at one week and six weeks after the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pocket depth	Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured	6 weeks

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 2022/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There will be not necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No