PRF Therapy for Pocket Reduction

Not Applicable

Completed

• Conditions: Periodontitis; Periodontal Pocket
• Interventions: Procedure: SRP and concomitant insertion of PRF membrane; Procedure: SRP

• Registration Number: NCT05908929
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-02-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients treated with SRP and insertion of PRF	SRP and concomitant insertion of PRF membrane	-
patients treated with SRP	SRP	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Università degli Studi di Napoli Federico II; 🇮🇹 Napoli, Italy

University of Naples Federico II; 🇮🇹 Naples, Italy