Effects of Hyaluronic Acid and Corticosteroid in Post Extraction Wound Healing of Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.
详细描述
After sample size estimation via Open Epi of 128, randomized clinical trial was performed on the patients from Oral and Maxillofacial Surgery Department in Madinah Teaching Hospital, Faisalabad. Patients were divided into three groups. Group 1 was subjected as control group, Group 2 was treated post extraction with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) and Group 3 was treated with single dose Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals Pakistan) intramuscularly after extraction. Wound healing was assessed through Landry Healing Index. One-way ANOVA test was applied for comparative analysis and Post Hoc Tuckey's test was applied for pairwise comparisons between the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization.
- •Age was defined from 25-55, irrespective of the gender.
- •Tooth extractions in maxilla or mandible without the presence of an acute infection or compromised periodontal state.
排除标准
- •• Patients who declined to participate.
- •Patients below the age of 25 and above the age of
- •Patients with uncontrolled diabetes mellitus (blood sugar levels high than the defined range)
- •Patients with history of adverse effects to local anesthetics or who are currently taking corticosteroids.
- •Patients with unmaintained oral hygiene and smoking habits.
- •Confirmation of any chronic illness, including those with hypertension or cardiac disorders.
- •Patients who have undergone any recent major surgical procedure.
研究组 & 干预措施
Group 2
Patients treated with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) applied in extraction socket.
干预措施: Hyaluronic Acid (HA) (Drug)
Group 3
The extraction socket of these patients were treated with a single dose of Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals, Pakistan).
干预措施: Corticosteroid Injection (Drug)
结局指标
主要结局
Wound healing
时间窗: 6 days
The wound healing after follow was assessed via Landry Healing Index. This index had five grades very poor (1), poor (2), good (3), very good (4) and excellent (5). Each grade further had five parameters that included tissue color, response to palpation, granulation tissue, incision margin and suppuration. Tissue color was further categorized into \>50% of red gingiva for grade 1 and 2. For grade 3 tissue color was specified as 25-50% of red gingiva. Less than 25% for grade 4 and all pink tissues for grade 5.Response to palpation was assessed as yes for grade 1 and 2, and no for the remaining three grades. The presence of granulation tissue was examined as yes for grade 1 and 2, and no for grade 3, 4 and 5. If the Incision margin was not epithelialized with loss of epithelium beyond incision margin it was considered grade 1. Incision margin not epithelialized with connective tissue exposure was marked as grade 2. For grade 3, 4 and 5, the connective tissue exposure was nil.
次要结局
未报告次要终点
研究者
Rimsha Rasheed
Dr. Rimsha Rasheed
University of Faisalabad