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Completed

NCT Number: NCT05871190

The Effects Of I-PRF On Gingivectomy and Gingivoplasty

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.

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Key information

Conditions

Wound Heal

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences; Ankara, Turkey

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Other names: i-prf

Gingivectomy anad gingivoplasty

Procedure

leveling and regulation of the gingiva

Primary outcomes

  1. effects of I-PRF on wound healing and epithelialization

    Time frame: seven months

    I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.

Secondary outcomes

  1. effects of biochemical markers on wound healing

    Time frame: seven months

    In order to see the effects of biochemical markers on wound healing, gingival crevicular fluid samples should be taken at more frequent intervals.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Afyonkarahisar Health Sciences University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 23, 2023
Registry last updated
May 23, 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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