Effects of i-PRF on Non-surgical Periodontal Treatment

NCT05753631 | Completed DMC

• 1 other identifier: 22.02.2022/04
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. The low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. It also contributes to the wound-healing process by increasing vascularization. It is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. For this reason, in this study it was aimed to investigate the early effects of injectable PRF applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid

Conditions

Platelet-Rich Fibrin

Keywords

platelet-rich fibrin; non-surgical periodontal treatment; wound healing; growth factor; cytokine

Outcome Measures

Primary Outcomes (8)

• GCF VEGF levels in test and control groups

  measure and compare the improvement of VEGF in test and control groups by using ELISA

  Change from Baseline GCF VEGF levels at 3rd and 7th days

• GCF TNF-alpha levels in test and control groups

  measure and compare the improvement of TNF-alpha in test and control groups by using ELISA

  Change from Baseline GCF TNF-alpha levels at 3rd and 7th days

• GCF IL-10 levels in test and control groups

  measure and compare the improvement of IL-10 in test and control groups by using ELISA

  Change from Baseline GCF IL-10 levels at 3rd and 7th days

• Plaque index (PI)

  measure and compare the improvement of PI in test and control groups using a scale

  Change from Baseline PI at 3rd and 7th days

• Probing depth (PD)

  measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups

  Change from Baseline PD levels at 3rd and 7th days

• Gingival index (GI)

  measure and compare the improvement of GI in test and control groups using a scale

  Change from Baseline GI at 3rd and 7th days

• Bleeding on probing (BOP)

  Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups

  Change from Baseline BOP at 3rd and 7th days

• Clinical attachment level (CAL)

  measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups

  Change from Baseline CAL at 3rd and 7th days

Study Arms (2)

SRP+i-PRF (test)

Injectable platelet-rich fibrin (i-PRF) application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure.

Procedure: non surgical periodontal treatment

SRP (Control)

No agent was applied to the periodontal pocket after scaling and root planning.

Procedure: non surgical periodontal treatment

Interventions

non surgical periodontal treatment PROCEDURE

scaling and root planning were applied for non-surgical periodontal treatment i-PRF application: Intravenous blood sample taken from the antecubital vein of the patients was collected in a 10 ml tube and centrifuged at 700 rpm for 3 minutes in a PRF centrifuge device. The PRF obtained from the upper liquid layer formed in the tube was injected subgingival into the deepest point of the pocket after SRP treatment. Clinical periodontal measurements: plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing, and gingival recession were calculated. gingival crevicular fluid: Perio papers were placed in the deepest part of the sulcus and left for 30 seconds. After 30 seconds, the paper strips were placed in the periotron device and the volume was calculated.

Also known as: i-PRF application, clinical periodontal measurement taken, gingival crevicular fluid obtained

SRP (Control); SRP+i-PRF (test)

Eligibility Criteria

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

Study Population

Patients with systemically healthy and stage 3 grade B periodontitis aged 18-65

You may qualify if:

• patients with stage 3 grade B periodontitis

You may not qualify if:

• patients with systemic disease
• pregnant and breastfeeding
• acute or chronic infection in the past 6 months
• Use of systemic antibiotic therapy in the past 6 months
• use of drugs that can affect periodontal health
• receiving hormone therapy
• smokers
• teeth with endodontic lesions
• Teeth with class 2 and 3 mobility

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Gizem Torumtay Cin

Denizli, Deni̇zli̇, 20070, Turkey (Türkiye)

Location

Related Publications (3)

• Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.

  PMID: 28154995 BACKGROUND

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 RESULT

• Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.

  PMID: 38153510 DERIVED

Study Officials

• Gizem Torumtay Cin, PhD

  pamukkale university faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: March 3, 2023
• Study Start: February 2, 2022
• Primary Completion: November 15, 2022
• Study Completion: January 15, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

TU (1)