Chitosan and i-PRF in Palatal Wound Healing

NCT ID: NCT07072546

Last Updated: 2026-01-27

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2025-12-10

Brief Summary

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This study aims to evaluate the effects of chitosan and injectable platelet-rich fibrin (i-PRF) on wound healing at the donor site following free gingival graft (FGG) procedures. The palatal donor area often experiences delayed healing and postoperative discomfort, motivating the search for effective biomaterials to enhance recovery and reduce patient morbidity. Although various approaches have been investigated, the combined application of chitosan and i-PRF has not yet been explored in this context.

The study examines three patient groups treated at the periodontology departments of Çukurova and Biruni University: one with gelatin sponge (control), one with chitosan, and one with chitosan infused with i-PRF. Parameters such as pain (VAS), bleeding, burning sensation, dietary changes, epithelialization (PEHI score), and color match were assessed over a 2-month follow-up.

The findings are expected to provide insights into whether i-PRF-enhanced chitosan offers superior healing outcomes and greater patient comfort compared to conventional methods.

Detailed Description

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Conditions

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Free Gingival Graft Wound Healing i-PRF Chitosan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

control group

Group Type OTHER

free gingival graft + gelatin sponge

Intervention Type PROCEDURE

Free gingival graft surgery and application of gelatin sponge to the palatal wound

chitosan

Group Type ACTIVE_COMPARATOR

free gingival graft + chitosan

Intervention Type PROCEDURE

free gingival graft surgery and application of chitosan to the palatal wound

chitosan-iprf

Group Type EXPERIMENTAL

free gingival graft + chitosan and i-PRF

Intervention Type PROCEDURE

free gingival graft surgery and application of chitosan and i-PRF to the palatal wound

Interventions

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free gingival graft + gelatin sponge

Free gingival graft surgery and application of gelatin sponge to the palatal wound

Intervention Type PROCEDURE

free gingival graft + chitosan

free gingival graft surgery and application of chitosan to the palatal wound

Intervention Type PROCEDURE

free gingival graft + chitosan and i-PRF

free gingival graft surgery and application of chitosan and i-PRF to the palatal wound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Periodontally healthy
* Having good oral hygiene (plaque accumulation \<20%)
* Requiring a free gingival graft (FGG) procedure in an area with insufficient keratinized gingiva width (\<2 mm)

Exclusion Criteria

* Having systemic diseases contraindicating surgical procedures,
* Uncontrolled diabetes (HbA1c \> 7),
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease,
* Smokers (≥ 10 cigarettes per day)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role collaborator

Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Burcu KARADUMAN

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Chitosan-iPRF

Identifier Type: -

Identifier Source: org_study_id

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