The Effects Of I-PRF On Gingivectomy and Gingivoplasty

The Effects Of Injectable Platelet-Rich Fibrin Application On Wound Healing Following Gingivectomy and Gingivoplasty Operations: Single-blind, Randomized Controlled, Prospective Clinical Study

The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain level.

Considering the results found, I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Other: İnjectable platelet rich fibrin; Procedure: Gingivectomy anad gingivoplasty

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • University of Health Sciences; Ankara, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

(a) systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene.

Exclusion Criteria:

(a) patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; I-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing	Other: İnjectable platelet rich fibrin; I-PRF is a type of platelet-rich fibrin (PRF) product obtained from the patient's own blood. PRF is a kind of tissue regeneration product of blood, rich in platelets, growth factors and cellular components.; Other Names: i-prf; Procedure: Gingivectomy anad gingivoplasty; leveling and regulation of the gingiva
Placebo Comparator: control group; closure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method.	Procedure: Gingivectomy anad gingivoplasty; leveling and regulation of the gingiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of I-PRF on wound healing and epithelialization	I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.	seven months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of biochemical markers on wound healing	In order to see the effects of biochemical markers on wound healing, gingival crevicular fluid samples should be taken at more frequent intervals.	seven months

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Collaborators: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: şeyma ÇARDAKCI BAHAR, Lecturer, University of Health Sciences; Ankara, Turkey; Study Director: Nebi Cansın KARAKAN, Asst. Prof., Faculty of Dentistry Afyonkarahisar University of Health Sciences, Afyonkarahisar, Turkey; Study Chair: Ayhan VURMAZ, Assoc. Prof., Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: VEGF, FGF-10, I-PRF,gingivectomy
• Other Study ID Numbers: 21.DUS.005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year after the study was published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No