Clinical trial NCT05753631: Effects of i-PRF on Non-surgical Periodontal Treatment
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet-Rich Fibrin
Keywords: platelet-rich fibrin
non-surgical periodontal treatment
wound healing
growth factor
cytokine
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemically healthy and stage 3 grade B periodontitis aged 18-65

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: GCF VEGF levels in test and control groups
timeFrame: Change from Baseline GCF VEGF levels at 3rd and 7th days
measure: GCF TNF-alpha levels in test and control groups
timeFrame: Change from Baseline GCF TNF-alpha levels at 3rd and 7th days
measure: GCF IL-10 levels in test and control groups
timeFrame: Change from Baseline GCF IL-10 levels at 3rd and 7th days
measure: Plaque index (PI)
timeFrame: Change from Baseline PI at 3rd and 7th days
measure: Probing depth (PD)
timeFrame: Change from Baseline PD levels at 3rd and 7th days
measure: Gingival index (GI)
timeFrame: Change from Baseline GI at 3rd and 7th days
measure: Bleeding on probing (BOP)
timeFrame: Change from Baseline BOP at 3rd and 7th days
measure: Clinical attachment level (CAL)
timeFrame: Change from Baseline CAL at 3rd and 7th days
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Gizem Torumtay Cin
state: Deni̇zli̇
Study officials:
affiliation: pamukkale university faculty of dentistry
name: Gizem Torumtay Cin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.