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Clinical Trials/NCT05871190
NCT05871190
Completed
Not Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country46 target enrollmentAugust 23, 2021
ConditionsWound Heal

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wound Heal
Sponsor
Saglik Bilimleri Universitesi
Enrollment
46
Locations
1
Primary Endpoint
effects of I-PRF on wound healing and epithelialization
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2021
End Date
May 20, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Şeyma Çardakçı

Lecturer

Saglik Bilimleri Universitesi

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • effects of biochemical markers on wound healing(seven months)

Study Sites (1)

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