Injectable Platelet Rich Fibrin in Periodontal Treatment

NCT06814418 | Active Not Recruiting

• 1 other identifier: 234/21-03-2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled parallel clinical trial is to investigate the efficacy of injectable Platelet Rich Fibrin (iPRF) as an adjunctive to non-surgical periodontal therapy (STEP 1 \& 2 of periodontal treatment). Thirty-two (32) patients diagnosed with stage III periodontitis will be randomly assigned to two study groups. Participants will receive non-surgical periodontal treatment only (control group) or non-surgical periodontal treatment with iPRF (test group). Patients will receive step 1 and 2 of periodontal treatment. Step 2 of periodontal treatment will be completed in one visit. Test group also will receive immediately after the subgingival instrumentation iPRF at the sites with PPD≥5mm. Subgingival plaque will be collected with paper points at different time points- baseline: before treatment, 3 and 6 months after treatment. The presence and quantification of bacteria: -Porphyromonas gingivalis (Pg), Filifactor Alocis (F.Alocis)- will be examined with quantitative polymerase chain reaction (q PCR). Clinical parameters, including bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC) will be recorded at baseline, 3 and 6 months after treatment. Patient satisfaction will be assessed through questionnaires regarding quality of life, pain perception and the use of analgesics. The questionnaires will be completed one week after subgingival instrumentation.

Conditions

Periodontitis

Keywords

Periodontitis; Platelet Rich Fibrin; Non surgical; Porphyromonas gingivalis; Filifactor alocis; Pocket closure

Outcome Measures

Primary Outcomes (3)

• Pocket closure - Percentage of successful treatment outcome

  Pocket closure : clinical Periodontal Marker: probing pocket depth (PPD) ≤4 mm and absence of bleeding on probing (BOP). (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)

  6 months

• Bleeding on Probing (BoP) - Change in percentage

  Clinical Periodontal Marker: Bleeding after slight pressure by a standardized (dimensions and shape) periodontal probe with a controlled (∼0.25 N) force to the apical end of the sulcus (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)

  6 months

• Clinical Attachment Loss (CAL)

  Clinical Periodontal Marker: The distance in mm from the CEJ to the gingival margin (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)

  6 months

Secondary Outcomes (3)

• Microbiological Assessment

  6 months

• Patient-reported Outcomes

  1 week

• Analgesic Intake

  1 week

Study Arms (2)

Test

EXPERIMENTAL

Non-surgical periodontal treatment + injectable Platelet Rich Fibrin

Procedure: Non-surgical periodontal treatment; Procedure: Injectable Platelet Rich Fibrin (I-PRF)

Control

ACTIVE COMPARATOR

Non-surgical periodontal treatment

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment PROCEDURE

Step I and II of periodontal treatment.

Control; Test

Injectable Platelet Rich Fibrin (I-PRF) PROCEDURE

Infusion of I-PRF in sited with PPD≥5mm.

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages Eligible for Study: \>18 years old (Adults)
• Diagnosed Periodontitis Stage III
• Presence of ≥ 15 teeth
• Signed written consent form by patient

You may not qualify if:

• At least one edentulous jaw
• Need for chemoprophylaxis before treatment
• Periodontal treatment the last 6 months
• Antibiotic treatment the last 6 months
• Immunomodulatory diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis), for which patients do not take medication
• HbA1c\> 7.0% in patients with diabetes
• Pregnancy/ Lactation
• Medications or undergoing treatment which may affect mucosal healing

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

Related Publications (13)

• Ferrarotti F, Baima G, Rendinelli M, Citterio F, Mariani GM, Mussano F, Romano F, Romandini M, Aimetti M. Pocket closure after repeated subgingival instrumentation: a stress test to the EFP guideline for stage III-IV periodontitis. Clin Oral Investig. 2023 Nov;27(11):6701-6708. doi: 10.1007/s00784-023-05279-6. Epub 2023 Sep 29.

  PMID: 37773418 BACKGROUND

• D'Aiuto F, Ready D, Parkar M, Tonetti MS. Relative contribution of patient-, tooth-, and site-associated variability on the clinical outcomes of subgingival debridement. I. Probing depths. J Periodontol. 2005 Mar;76(3):398-405. doi: 10.1902/jop.2005.76.3.398.

  PMID: 15857074 BACKGROUND

• Moraschini V, Miron RJ, Mourao CFAB, Louro RS, Sculean A, da Fonseca LAM, Calasans Maia MD, Shibli JA. Antimicrobial effect of platelet-rich fibrin: A systematic review of in vitro evidence-based studies. Periodontol 2000. 2024 Feb;94(1):131-142. doi: 10.1111/prd.12529. Epub 2023 Sep 22.

  PMID: 37740425 BACKGROUND

• Ozcan E, Saygun I, Kantarci A, Ozarslanturk S, Serdar MA, Ozgurtas T. The effects of a novel non-invasive application of platelet-rich fibrin on periodontal clinical parameters and gingival crevicular fluid transforming growth factor-beta and collagen-1 levels: A randomized, controlled, clinical study. J Periodontol. 2021 Sep;92(9):1252-1261. doi: 10.1002/JPER.20-0713. Epub 2021 Jan 15.

  PMID: 33382101 BACKGROUND

• Narendran N, Anegundi RV, Shenoy SB, Chandran T. Autologous platelet-rich fibrin as an adjunct to non-surgical periodontal therapy-A follow up clinical pilot study. Wound Repair Regen. 2022 Jan;30(1):140-145. doi: 10.1111/wrr.12979. Epub 2021 Oct 22.

  PMID: 34687113 BACKGROUND

• Al-Rihaymee S, Sh Mahmood M. The efficacy of non-surgical platelet-rich fibrin application on clinical periodontal parameters and periostin level in periodontitis: Clinical trial. J Cell Mol Med. 2023 Feb;27(4):529-537. doi: 10.1111/jcmm.17675. Epub 2023 Jan 23.

  PMID: 36691719 BACKGROUND

• Sharma A, Pradeep AR. Autologous platelet-rich fibrin in the treatment of mandibular degree II furcation defects: a randomized clinical trial. J Periodontol. 2011 Oct;82(10):1396-403. doi: 10.1902/jop.2011.100731. Epub 2011 Feb 2.

  PMID: 21284545 BACKGROUND

• Bajaj P, Pradeep AR, Agarwal E, Rao NS, Naik SB, Priyanka N, Kalra N. Comparative evaluation of autologous platelet-rich fibrin and platelet-rich plasma in the treatment of mandibular degree II furcation defects: a randomized controlled clinical trial. J Periodontal Res. 2013 Oct;48(5):573-81. doi: 10.1111/jre.12040. Epub 2013 Jan 14.

  PMID: 23317096 BACKGROUND

• Ajwani H, Shetty S, Gopalakrishnan D, Kathariya R, Kulloli A, Dolas RS, Pradeep AR. Comparative evaluation of platelet-rich fibrin biomaterial and open flap debridement in the treatment of two and three wall intrabony defects. J Int Oral Health. 2015 Apr;7(4):32-7.

  PMID: 25954068 BACKGROUND

• Thorat M, Pradeep AR, Pallavi B. Clinical effect of autologous platelet-rich fibrin in the treatment of intra-bony defects: a controlled clinical trial. J Clin Periodontol. 2011 Oct;38(10):925-32. doi: 10.1111/j.1600-051X.2011.01760.x. Epub 2011 Jul 21.

  PMID: 21777267 BACKGROUND

• Pradeep AR, Rao NS, Agarwal E, Bajaj P, Kumari M, Naik SB. Comparative evaluation of autologous platelet-rich fibrin and platelet-rich plasma in the treatment of 3-wall intrabony defects in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2012 Dec;83(12):1499-507. doi: 10.1902/jop.2012.110705. Epub 2012 Feb 21.

  PMID: 22348695 BACKGROUND

• Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.

  PMID: 21513477 BACKGROUND

• Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.

  PMID: 28551729 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Leonidas Batas, Ass. Professor, DDS, MSc, PhD

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

• Sofia Zarenti, DDS

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: February 7, 2025
• Study Start: June 15, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)