The Effects Of I-PRF On Gingivectomy and Gingivoplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Heal

Intervention / Treatment
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* Other: İnjectable platelet rich fibrin
* Procedure: Gingivectomy anad gingivoplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group<br>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<br>* 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.<br>* Other names: i-prf;Procedure: Gingivectomy anad gingivoplasty<br>* leveling and regulation of the gingiva<br>|
| Placebo Comparator: control group<br>closure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method. | Procedure: Gingivectomy anad gingivoplasty<br>* leveling and regulation of the gingiva<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VEGF, FGF-10, I-PRF,gingivectomy