L-PRF Versus A-PRF on Palatal Wound Healing

NCT06242314 | Completed

• 1 other identifier: 1090/2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft harvesting and patients' quality of life.

Conditions

Palate; Wound

Keywords

free gingival graft; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• Epithelialization

  Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization

  1 month

Secondary Outcomes (3)

• Pain at Palatal wound area

  First 7 days and day 14

• Pain at Palatal wound area

  First 7 days

• Oral health-related quality of life (OHRQoL)

  7 and 14 days after free gingival graft surgery

Study Arms (3)

L-PRF

EXPERIMENTAL

L-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.

Procedure: L_PRF

A-PRF

EXPERIMENTAL

A-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.

Procedure: A-PRF

Palatal stent

PLACEBO COMPARATOR

Palatal stent was prepared by taking impression of the palate before surgery. After FGG harvesting, periodontal paste (COE-PAK periodontal dressing, GC, Illinois, USA) was applied on the wound surface of the palatal stent and the palate was closed.

Procedure: Palatal stent

Interventions

L_PRF PROCEDURE

Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after L-PRF placing on palatal wounds

L-PRF

A-PRF PROCEDURE

Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after A-PRF placing on palatal wounds

A-PRF

Palatal stent PROCEDURE

Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after palatal stent placing on palatal wounds

Palatal stent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients ≥18 years requiring FGG surgery because of shallow vestibule and insufficient keratinized/attached gingival width

You may not qualify if:

• no smoking /no alcohol use,
• not suffering from any systemic disease that could impair the healing of wounds,
• pregnancy or lactation,
• Previous graft harvesting from the same site.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Mehmet Sağlam

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 5, 2024
• Study Start: January 10, 2021
• Primary Completion: March 22, 2022
• Study Completion: October 24, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

TU (1)