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PRF Therapy for Pocket Reduction

Primary Purpose

Periodontal Pocket, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SRP and concomitant insertion of PRF membrane
SRP
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Naples Federico II
  • Università degli Studi di Napoli Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients treated with SRP and insertion of PRF

patients treated with SRP

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2023
Last Updated
June 16, 2023
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT05908929
Brief Title
PRF Therapy for Pocket Reduction
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients treated with SRP and insertion of PRF
Arm Type
Experimental
Arm Title
patients treated with SRP
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
SRP and concomitant insertion of PRF membrane
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SRP
Intervention Description
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 Outcome Measure Information:
Title
pocket depth
Description
Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80123
Country
Italy
Facility Name
Università degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
There will be not necessary

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PRF Therapy for Pocket Reduction

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