Clinical Trials Directory

Trials / Completed

CompletedNCT05908929

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Federico II University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDURESRP and concomitant insertion of PRF membraneThe 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.
PROCEDURESRPThe 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.

Timeline

Start date
2022-09-15
Primary completion
2023-01-15
Completion
2023-02-15
First posted
2023-06-18
Last updated
2023-06-18

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT05908929. Inclusion in this directory is not an endorsement.