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Completed

NCT Number: NCT05908929

PRF Therapy for Pocket Reduction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II, Naples, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. pocket depth

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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