Chitosan and i-PRF in Palatal Wound Healing

Not Applicable

Not yet recruiting

• Conditions: Free Gingival Graft; Wound Healing; i-PRF; Chitosan

• Registration Number: NCT07072546
• Lead Sponsor: Biruni University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study Start: 2025-07-10
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Palatal early healing index	Day 56	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).

Secondary Outcome Measures

Name	Time	Method
Pain	Day 56	The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Use of analgesics and palatal bleeding	Day 7	Patients will be given a form and asked to record this information daily.
Difficulty in chewing	Day 56	The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Graft dimentions	Day 0	The width, length, and thickness of the palatal graft will be measured using a periodontal probe and recorded.
Color match	Day 56	The color match at the donor site will be evaluated in comparison with the adjacent palatal area and the contralateral palatal arch by visual analogue scale (0-very bad to 10-excellent).
Burning sensation	Day 56	The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Changes in dietary habits	Day 56	The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).