The Effects Of I-PRF On Gingivectomy and Gingivoplasty

NCT ID: NCT05871190

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2022-05-20

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.

Detailed Description

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Conditions

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Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test group

I-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing

Group Type ACTIVE_COMPARATOR

İnjectable platelet rich fibrin

Intervention Type 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.

Gingivectomy anad gingivoplasty

Intervention Type PROCEDURE

leveling and regulation of the gingiva

control group

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

Group Type PLACEBO_COMPARATOR

Gingivectomy anad gingivoplasty

Intervention Type PROCEDURE

leveling and regulation of the gingiva

Interventions

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İnjectable platelet rich fibrin

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.

Intervention Type OTHER

Gingivectomy anad gingivoplasty

leveling and regulation of the gingiva

Intervention Type PROCEDURE

Other Intervention Names

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i-prf

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Şeyma Çardakçı

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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şeyma ÇARDAKCI BAHAR, Lecturer

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences; Ankara, Turkey

Nebi Cansın KARAKAN, Asst. Prof.

Role: STUDY_DIRECTOR

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

Ayhan VURMAZ, Assoc. Prof.

Role: STUDY_CHAIR

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

Locations

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University of Health Sciences; Ankara, Turkey

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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21.DUS.005

Identifier Type: -

Identifier Source: org_study_id

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