The Effects Of I-PRF On Gingivectomy and Gingivoplasty

NCT05871190 | Completed

• 1 other identifier: 21.DUS.005
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal

Keywords

VEGF, FGF-10, I-PRF,gingivectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• effects of biochemical markers on wound healing

  seven months

Study Arms (2)

Test group

ACTIVE COMPARATOR

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; Procedure: Gingivectomy anad gingivoplasty

control group

PLACEBO COMPARATOR

closure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method.

Procedure: Gingivectomy anad gingivoplasty

Interventions

İnjectable platelet rich fibrin OTHER

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.

Also known as: i-prf

Test group

Gingivectomy anad gingivoplasty PROCEDURE

leveling and regulation of the gingiva

Test group; control group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Afyonkarahisar Health Sciences University: collaborator

Study Sites (1)

University of Health Sciences; Ankara, Turkey

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

• şeyma ÇARDAKCI BAHAR, Lecturer

  University of Health Sciences; Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Nebi Cansın KARAKAN, Asst. Prof.

  Faculty of Dentistry Afyonkarahisar University of Health Sciences, Afyonkarahisar, Turkey

  STUDY DIRECTOR

• Ayhan VURMAZ, Assoc. Prof.

  Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: August 23, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 20, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year after the study was published

Locations

TU (1)