Effect of I-PRF After Gingivectomy

NCT07174934 | Not Yet Recruiting DMC

• 1 other identifier: P-ME-25-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of injectable platelet-rich fibrin application on wound healing following gingivectomy or gingivoplasty. The main question it aims to answer are: Does the injectable platelet-rich fibrin enhance the wound healing after gingivectomy or gingivoplasty ? Participants(who have chronic inflammatory gingival overgrowth) will be divided into two groups : Group I: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control). Group II: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty and application of injectable platelet rich fibrin on wound area. The patients will be recalled for follow-up appointments on days 7, 14, and 21.

Conditions

Chronic Inflammatory Gingival Enlargement

Outcome Measures

Primary Outcomes (1)

• Change in gingival crevicular fluid level of Vascular Endothelial Growth Factor (VEGF) at baseline and 21 days after gingivectomy or gingivoplasty.

  at baseline, 21days after gingivectomy.

Secondary Outcomes (3)

• Patient satisfaction using Visual Analog Scale (VAS).

  At 7th ,14th,21th days after gingivectomy.

• Clinical wound healing using Landry, Turnbull, and Howley (LTH) Wound Healing Index.

  7th, 14th, 21st days after gingivectomy.

• Clinical wound healing using Modified Manchester Scar (MMS) Scale.

  7th, 14th, 21st days after gingivectomy.

Study Arms (2)

application of injectable platelet-rich fibrin after gingivectomy or gingivoplasty .

ACTIVE COMPARATOR

10 systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty and application of injectable platelet rich fibrin on wound area.

Biological: application of injectable platelet-rich fibrin on the wound area .

gingivectomy or gingivoplasty alone

NO INTERVENTION

10 systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control).

Interventions

application of injectable platelet-rich fibrin on the wound area . BIOLOGICAL

Injectable platelet-rich fibrin will be prepared using low speed centrifugation technique, after centrifugation, the I-PRF in the upper part of the tube will be collected via an injector and will be transferred to a metal godet. It will be left for 15-20 min for polymerization of the I-PRF ,Then the polymerized I-PRF will be applied to the secondary wound of test area.

application of injectable platelet-rich fibrin after gingivectomy or gingivoplasty .

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients. 2- patients ages18-35years. 3- patients with chronic inflammatory gingival overgrowth. 4- patients with fibrotic gingival overgrowth. 5- Patients with enough attached gingiva. 6- Patients signing informed written consent.

You may not qualify if:

• \- 1) Pregnancy or lactation. 2) Any known systemic disease. 3) Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
• \) smokers and alcohol users 5) clinical attachment or bone loss. 6) Patients run on 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Out-Patient Clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dental Medicine for Girls, Al-Azhar University.

Cairo, Egypt

Location

Central Study Contacts

Eman A Elgharib, General dentist

CONTACT

01026551088; e23e145a@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and Care Provider will be masked about type of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist at Egyptian Ministry of Health

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)