L-PRF Versus A-PRF on Palatal Wound Healing

Not Applicable

Completed

• Conditions: Palate; Wound
• Interventions: Procedure: L_PRF; Procedure: Palatal stent; Procedure: A-PRF

• Registration Number: NCT06242314
• Lead Sponsor: Izmir Katip Celebi University

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.

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 Timeline

• Study Start: 2021-01-10
• Primary Completion: 2022-03-22
• Study Completion: 2022-10-24
• Study First Submitted: 2024-01-25
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-PRF	L_PRF	L-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.
Palatal stent	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.
A-PRF	A-PRF	A-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture.

Primary Outcome Measures

Name	Time	Method
Epithelialization	1 month	Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization

Secondary Outcome Measures

Name	Time	Method
Pain at Palatal wound area	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.
Oral health-related quality of life (OHRQoL)	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.

Trial Locations

Locations (1)

Mehmet Sağlam; 🇹🇷 İzmir, Çiğli, Turkey