Skip to main content
OpenTrials
Completed

NCT Number: NCT06242314

L-PRF Versus A-PRF on Palatal Wound Healing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Palate; Wound Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mehmet Sağlam

Izmir, Çiğli, 35640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. Epithelialization

    Time frame: 1 month

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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.