L-PRF Versus A-PRF on Palatal Wound Healing

February 2, 2024 updated by: Prof.Dr. Mehmet Sağlam, Izmir Katip Celebi University

Comparison of The Effect of A-PRF and L-PRF Application to The Palatal Region on Quality of Life and Wound Healing After Free Gingival Graft Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had completed Phase 1 periodontal treatments and for whom FGG surgery was indicated for isolated gingival recession defects limited to one or two teeth with shallow vestibule and insufficient keratinized or attached gingival width were included in the present study.

Three different treatments were performed on palatal wound areas: L-PRF (L-PRF group, n = 12), A-PRF (A-PRF group, n = 12) and palatal stent (control group, n = 12) OHIP-14 scores, VAS scores (for pain), analgesic tablet intake, and epithelialization condition were recorded for different time points.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çiğli
      • İzmir, Çiğli, Turkey, 35640
        • Mehmet Sağlam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-PRF
L-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.
Procedure: L_PRF
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
Experimental: A-PRF
A-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.
Procedure: A-PRF
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
Placebo Comparator: Palatal stent
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelialization
Time Frame: 1 month
Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at Palatal wound area
Time Frame: First 7 days and day 14
Postoperative pain was evaluated using a 10-cm Visual Analog Scale (VAS) score during the first week and on day 14. The left end-point represented "no pain," while the right end-point represented "severe pain at its highest." In order to rate their pain, the participants were requested to indicate the VAS line with the appropriate postoperative pain level. A ruler was then used to measure the distance between the "no pain" point and the rated line, providing a pain score between 0 and 10
First 7 days and day 14
Pain at Palatal wound area
Time Frame: First 7 days
The average amount of ibuprofen 600 mg pills needed to control postoperative discomfort during the seven days after surgery was recorded as the total number of pills consumed.
First 7 days
Oral health-related quality of life (OHRQoL)
Time Frame: 7 and 14 days after free gingival graft surgery
Oral health-related quality of life of patients was assessed by the Oral Health Impact Profile-14 (OHIP-14) questionnaire.OHIP-14 uses 14 structured questions and answers to assess seven subjective dimensions. The evaluated dimensions are functional limitations, physical pain, psychologic discomfort, physical disability, psychologic disability, social disability, and handicap. Patients responded to the questionnaire using Likert scale answers (0- never; 1-almost never; 2-occasionally; 3-quite frequent; 4-very common) on the 7th and 14th day after surgery. In this way, the questionnaire ranges from 0 to 56 points, with higher scores indicating more negative impact of oral conditions on quality of life.Thus, patients' experiences about the surgery in the first two weeks postoperatively were recorded.
7 and 14 days after free gingival graft surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1090/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Palate; Wound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe