Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wound healing (Landry Healing Index)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting.
Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite.
Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively.
The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.
详细描述
This study is a randomized controlled clinical trial designed to evaluate the effect of different palatal dressing materials on wound healing following free gingival graft harvesting.
The study will be conducted at the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University, after approval of the Research Ethics Committee and Faculty Council. Thirty systemically healthy patients diagnosed with mucogingival defects requiring free gingival graft procedures will be recruited according to predefined inclusion and exclusion criteria. All participants will sign an informed consent form prior to enrollment.
Patients will be randomly allocated into three equal groups (n = 10 per group) using a computer-generated randomization method. Group A (control group) will receive a gelatin sponge covered with flowable composite on the palatal donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel (Blue®m) covered with a gelatin sponge and flowable composite.
Free gingival grafts will be harvested using the classical Sullivan and Atkins technique. The grafts will be adapted and sutured at the recipient site using resorbable sutures. At the donor site, hemostasis will be achieved using pressure with adrenaline-soaked gauze, followed by application of the assigned dressing protocol for each group.
Postoperative care will include analgesics (Ibuprofen 600 mg as needed), chlorhexidine mouth rinse (0.12%) twice daily for two weeks, and standard postoperative instructions. Patients will be recalled after 1 week for evaluation and removal/reapplication of the dressing when indicated, and again at 2 and 4 weeks for follow-up assessments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (>3 mm) Cooperative and motivated patients Good oral hygiene compliance
排除标准
- •Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection
研究组 & 干预措施
Active oxygen group (Blue®m)
Participants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
干预措施: Active oxygen gel (Drug)
Control group
Participants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management.
干预措施: Gelatin sponge with flowable composite (Procedure)
Hyaluronic acid group
Participants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
干预措施: Hyaluronic Acid gel (Drug)
结局指标
主要结局
Wound healing (Landry Healing Index)
时间窗: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing. The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.
次要结局
- Complete epithelialization (Hydrogen peroxide test)(1 week, 2 weeks, 3 weeks and 4 weeks postoperatively)
- Two-dimensional wound area reduction(Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively)
- Postoperative pain (VAS score)(Daily for the first postoperative week (Day 1 to Day 7))