L-PRF Versus A-PRF on Palatal Wound Healing

Palate; Wound Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06242314
• Other study ID #: 1090/2020
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: February 2024
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 24, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Palate; Wound
• Wounds and Injuries

Intervention

Procedure:
• L_PRF
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Pro?le-14 (OHIP-14) questionnaire scores were recorded after L-PRF placing on palatal wounds
• A-PRF
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Pro?le-14 (OHIP-14) questionnaire scores were recorded after A-PRF placing on palatal wounds
• Palatal stent
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Pro?le-14 (OHIP-14) questionnaire scores were recorded after palatal stent placing on palatal wounds

Locations

Country	Name	City	State
Turkey	Mehmet Saglam	Izmir	Çigli

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelialization	Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization	1 month
Secondary	Pain at Palatal wound area	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
Secondary	Pain at Palatal wound area	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
Secondary	Oral health-related quality of life (OHRQoL)	Oral health-related quality of life of patients was assessed by the Oral Health Impact Pro?le-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