L-PRF Versus A-PRF on Palatal Wound Healing

NCT ID: NCT06242314

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2022-10-24

Brief Summary

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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

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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.

Conditions

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Palate; Wound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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L-PRF

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

Group Type EXPERIMENTAL

L_PRF

Intervention Type 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

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

Group Type EXPERIMENTAL

A-PRF

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Palatal stent

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Prof.Dr. Mehmet Sağlam

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mehmet Sağlam

Izmir, Çiğli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1090/2020

Identifier Type: -

Identifier Source: org_study_id

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