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Completed

NCT Number: NCT05753631

Effects of i-PRF on Non-surgical Periodontal Treatment

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

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Key information

Conditions

Platelet-rich Fibrin

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gizem Torumtay Cin

Denizli, Deni̇zli̇, 20070, Turkey (Türkiye)

About this study

The study was planned as a randomized controlled split-mouth clinical trial. A split-mouth design was used to better assess how the same host responded to two different treatment modalities. Two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups.

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

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

On the first visit, clinical periodontal measurements were taken before the SRP procedure. Plague index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were used as clinical periodontal parameters.

After 1 week, the patients were called again for the SRP procedure. Injectable PRF obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the SRP procedure in the test group. Clinical periodontal measurements at 1 month and 3 months after SRP were repeated.

Gingival crevicular fluid (GCF) samples were taken from selected teeth before the SRP procedure. On the 3rd and 7th day after the SRP, GCF samples were taken again from the same region.

GCF vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), and interleukin (IL)-10 levels were evaluated by using the ELISA method and compared between groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with stage 3 grade B periodontitis

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: i-PRF application, clinical periodontal measurement taken, gingival crevicular fluid obtained

Primary outcomes

  1. GCF VEGF levels in test and control groups

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

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

  2. GCF TNF-alpha levels in test and control groups

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

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

  3. GCF IL-10 levels in test and control groups

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

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

  4. Plaque index (PI)

    Time frame: Change from Baseline PI at 3rd and 7th days

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

  5. Probing depth (PD)

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

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

  6. Gingival index (GI)

    Time frame: Change from Baseline GI at 3rd and 7th days

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

  7. Bleeding on probing (BOP)

    Time frame: Change from Baseline BOP at 3rd and 7th days

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

  8. Clinical attachment level (CAL)

    Time frame: Change from Baseline CAL at 3rd and 7th days

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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Evaluation of the Effects of Injectable Platelet-rich Fibrin (i-PRF) Application on Periodontal Clinical and Biochemical Parameters in Gingival Crevicular Fluid (GCF) in Non-surgical Periodontal Treatment

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Mar 3, 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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