The Effects Of I-PRF On Gingivectomy and Gingivoplasty

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871190
• Other study ID #: 21.DUS.005
• Status: Completed
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 20, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal

Intervention

Other:
• Injectable 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.

Procedure:
• Gingivectomy anad gingivoplasty
leveling and regulation of the gingiva

Locations

Country	Name	City	State
Turkey	University of Health Sciences; Ankara, Turkey	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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