Effects of Chitosan and i-PRF on Wound Healing After Palatal Graft Harvesting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Palatal early healing index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
control
control group
干预措施: free gingival graft + gelatin sponge (Procedure)
chitosan
干预措施: free gingival graft + chitosan (Procedure)
chitosan-iprf
干预措施: free gingival graft + chitosan and i-PRF (Procedure)
结局指标
主要结局
Palatal early healing index
时间窗: 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).
Palatal early healing index
时间窗: 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).
Palatal early healing index
时间窗: 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).
Palatal early healing index
时间窗: 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).
次要结局
- Use of analgesics and palatal bleeding(Day 7)
- Burning sensation(Day 56)
- Changes in dietary habits(Day 56)
- Use of analgesics and palatal bleeding(Day 1)
- Difficulty in chewing(Day 7)
- Difficulty in chewing(Day 14)
- Difficulty in chewing(Day 28)
- Use of analgesics and palatal bleeding(Day 2)
- Use of analgesics and palatal bleeding(Day 3)
- Use of analgesics and palatal bleeding(Day 4)
- Use of analgesics and palatal bleeding(Day 5)
- Use of analgesics and palatal bleeding(Day 6)
- Color match(Day 14)
- Color match(Day 28)
- Burning sensation(Day 1)
- Burning sensation(Day 3)
- Burning sensation(Day 7)
- Burning sensation(Day 14)
- Burning sensation(Day 28)
- Changes in dietary habits(Day 1)
- Changes in dietary habits(Day 3)
- Changes in dietary habits(Day 7)
- Changes in dietary habits(Day 14)
- Changes in dietary habits(Day 28)
- 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)
- Palatal Pain score(Day 56)
- Difficulty in chewing(Day 56)
- Graft dimentions(Day 0)
- Color match(Day 56)
研究者
Burcu KARADUMAN
Prof.
Biruni University