An interventional study of free gingival graft + gelatin sponge and free gingival graft + chitosan in Free Gingival Graft, Wound Healing and i-PRF, sponsored by Biruni University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
Biruni University is the lead sponsor of 172 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
control group
Procedure: free gingival graft + gelatin sponge
Procedure: free gingival graft + chitosan
Procedure: free gingival graft + chitosan and i-PRF
Free gingival graft surgery and application of gelatin sponge to the palatal wound
free gingival graft surgery and application of chitosan to the palatal wound
free gingival graft surgery and application of chitosan and i-PRF to the palatal wound
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 56
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 1
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 3
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 7
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 14
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 28
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Time frame: Day 56
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this informations daily.
Time frame: Day 1
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 7
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 14
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 28
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 56
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 2
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 3
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 4
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 5
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 6
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Time frame: Day 7
Graft dimentions
The width, length, and thickness of the palatal graft will be measured using a periodontal probe and recorded.
Time frame: Day 0
Color match
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).
Time frame: Day 14
Color match
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).
Time frame: Day 28
Color match
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).
Time frame: Day 56
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 1
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 3
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 7
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 14
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 28
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Time frame: Day 56
Changes in dietary habits
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).
Time frame: Day 1
Changes in dietary habits
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).
Time frame: Day 3
Changes in dietary habits
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).
Time frame: Day 7
Changes in dietary habits
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).
Time frame: Day 14
Changes in dietary habits
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).
Time frame: Day 28
Changes in dietary habits
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).
Time frame: Day 56
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Biruni University