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| Name | Class |
|---|---|
| Cukurova University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | control group |
|
| chitosan | Active Comparator |
| |
| chitosan-iprf | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| free gingival graft + gelatin sponge | Procedure | Free gingival graft surgery and application of gelatin sponge to the palatal wound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | Turkey (Türkiye) | ||||
| Biruni University |
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| ID | Term |
|---|---|
| D048271 | Chitosan |
| C043309 | proliferation regulatory factors, human urine |
| ID | Term |
|---|---|
| D002686 | Chitin |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| 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 |
|
| Day 56 |
| 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). | 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). | 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). | 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). | Day 56 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this informations daily. | 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). | 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). | 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). | 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). | Day 56 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 2 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 3 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 4 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 5 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 6 |
| Use of analgesics and palatal bleeding | Patients will be given a form and asked to record this information daily. | Day 7 |
| Graft dimentions | The width, length, and thickness of the palatal graft will be measured using a periodontal probe and recorded. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Day 56 |
| Istanbul |
| Turkey (Türkiye) |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |