Chitosan and i-PRF in Palatal Wound Healing

NCT07072546 | Completed

• 1 other identifier: Chitosan-iPRF
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Wound Healing; i-PRF; Chitosan; Free Gingival Graft

Outcome Measures

Primary Outcomes (4)

• Palatal early healing index

  The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).

  Day 7

• Palatal early healing index

  The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).

  Day 14

• Palatal early healing index

  The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).

  Day 28

• Palatal early healing index

  The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).

  Day 56

Secondary Outcomes (33)

• Palatal Pain score

  Day 1

• Palatal Pain score

  Day 3

• Palatal Pain score

  Day 7

• Palatal Pain score

  Day 14

• Palatal Pain score

  Day 28

Study Arms (3)

control

OTHER

control group

Procedure: free gingival graft + gelatin sponge

chitosan

ACTIVE COMPARATOR

Procedure: free gingival graft + chitosan

chitosan-iprf

EXPERIMENTAL

Procedure: free gingival graft + chitosan and i-PRF

Interventions

free gingival graft + chitosan and i-PRF PROCEDURE

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

chitosan-iprf

free gingival graft + gelatin sponge PROCEDURE

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

control

free gingival graft + chitosan PROCEDURE

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

chitosan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cukurova University: collaborator
• Biruni University: lead

Study Sites (2)

Cukurova University

Adana, Turkey (Türkiye)

Location

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Chitosan; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 18, 2025
• Study Start: July 12, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (2)