Clinical trial NCT05871190: The Effects Of I-PRF On Gingivectomy and Gingivoplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: VEGF, FGF-10, I-PRF,gingivectomy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Afyonkarahisar Health Sciences University
First posted: 2023-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: effects of I-PRF on wound healing and epithelialization
timeFrame: seven months
Secondary outcomes:
measure: effects of biochemical markers on wound healing
timeFrame: seven months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences; Ankara, Turkey
Study officials:
affiliation: University of Health Sciences; Ankara, Turkey
name: şeyma ÇARDAKCI BAHAR, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry Afyonkarahisar University of Health Sciences, Afyonkarahisar, Turkey
name: Nebi Cansın KARAKAN, Asst. Prof.
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey
name: Ayhan VURMAZ, Assoc. Prof.
role: STUDY_CHAIR
References: