PRF Therapy for Pocket Reduction

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05908929
• Collaborator: (none)
• Enrollment: 13
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site: 6.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Pocket; Periodontitis	Procedure: SRP and concomitant insertion of PRF membrane; Procedure: SRP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 15, 2022
• Actual Primary Completion Date: Jan 15, 2023
• Actual Study Completion Date: Feb 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. pocket depth [6 weeks]

   Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II	Naples		Italy	80123
2	Università degli Studi di Napoli Federico II	Napoli		Italy	80131

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Niccoló Giuseppe Armogida, Doctor in Dental Sciences, Principal Investigator, Federico II University
• ClinicalTrials.gov Identifier: NCT05908929
• Other Study ID Numbers: 2022/2023
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Periodontal Pocket

Study Results

No Results Posted as of Jun 18, 2023