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Completed

NCT Number: NCT07072546

Chitosan and i-PRF in Palatal Wound Healing

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.

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Key information

Conditions

Free Gingival Graft Chitosan Wound Healing i-PRF

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University, Adana, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

free gingival graft + gelatin sponge

Procedure

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

free gingival graft + chitosan

Procedure

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

free gingival graft + chitosan and i-PRF

Procedure

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

Primary outcomes

  1. Palatal early healing index

    Time frame: Day 7

    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).

  2. Palatal early healing index

    Time frame: Day 14

    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).

  3. Palatal early healing index

    Time frame: Day 28

    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).

  4. Palatal early healing index

    Time frame: 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 outcomes

  1. Palatal Pain score

    Time frame: Day 1

    The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).

  2. Palatal Pain score

    Time frame: Day 3

    The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).

  3. Palatal Pain score

    Time frame: Day 7

    The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).

  4. Palatal Pain score

    Time frame: Day 14

    The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).

  5. Palatal Pain score

    Time frame: Day 28

    The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).

  6. Palatal Pain score

    Time frame: 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).

  7. Use of analgesics and palatal bleeding

    Time frame: Day 1

    Patients will be given a form and asked to record this informations daily.

  8. Difficulty in chewing

    Time frame: Day 7

    The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  9. Difficulty in chewing

    Time frame: Day 14

    The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  10. Difficulty in chewing

    Time frame: Day 28

    The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  11. Difficulty in chewing

    Time frame: 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).

  12. Use of analgesics and palatal bleeding

    Time frame: Day 2

    Patients will be given a form and asked to record this information daily.

  13. Use of analgesics and palatal bleeding

    Time frame: Day 3

    Patients will be given a form and asked to record this information daily.

  14. Use of analgesics and palatal bleeding

    Time frame: Day 4

    Patients will be given a form and asked to record this information daily.

  15. Use of analgesics and palatal bleeding

    Time frame: Day 5

    Patients will be given a form and asked to record this information daily.

  16. Use of analgesics and palatal bleeding

    Time frame: Day 6

    Patients will be given a form and asked to record this information daily.

  17. Use of analgesics and palatal bleeding

    Time frame: Day 7

    Patients will be given a form and asked to record this information daily.

  18. Graft dimentions

    Time frame: Day 0

    The width, length, and thickness of the palatal graft will be measured using a periodontal probe and recorded.

  19. Color match

    Time frame: Day 14

    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).

  20. Color match

    Time frame: Day 28

    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).

  21. Color match

    Time frame: 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).

  22. Burning sensation

    Time frame: Day 1

    The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  23. Burning sensation

    Time frame: Day 3

    The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  24. Burning sensation

    Time frame: Day 7

    The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  25. Burning sensation

    Time frame: Day 14

    The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  26. Burning sensation

    Time frame: Day 28

    The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).

  27. Burning sensation

    Time frame: 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).

  28. Changes in dietary habits

    Time frame: Day 1

    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).

  29. Changes in dietary habits

    Time frame: Day 3

    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).

  30. Changes in dietary habits

    Time frame: Day 7

    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).

  31. Changes in dietary habits

    Time frame: Day 14

    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).

  32. Changes in dietary habits

    Time frame: Day 28

    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).

  33. Changes in dietary habits

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • Cukurova University

Registry information

Official study title

Effects of Chitosan and i-PRF on Wound Healing After Palatal Graft Harvesting

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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