PRF Therapy for Pocket Reduction

NCT05908929 | Completed DMC

• 1 other identifier: 2022/2023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Pocket; Periodontitis

Outcome Measures

Primary Outcomes (1)

• pocket depth

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

  6 weeks

Study Arms (2)

patients treated with SRP and insertion of PRF

EXPERIMENTAL

Procedure: SRP and concomitant insertion of PRF membrane

patients treated with SRP

ACTIVE COMPARATOR

Procedure: SRP

Interventions

SRP and concomitant insertion of PRF membrane PROCEDURE

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.

patients treated with SRP and insertion of PRF

SRP PROCEDURE

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.

patients treated with SRP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

University of Naples Federico II

Naples, 80123, Italy

Location

Università degli Studi di Napoli Federico II

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Dental Sciences, Principal Investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: September 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: February 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

IT (2)