NCT05543434招募中不适用
Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical attachment level gain
研究概览
简要总结
sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.
详细描述
To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years.
- •Patient with controlled diabetic type 2 (HgA1C <7) (Mori et al., 2021).
- •Periodontitis stage II.
- •Periodontitis grade B.
- •Pocket depth > 4 mm.
- •Smoking ≤ 10 cigarettes/day.
- •Cooperative patients able and accept to come for follow up appointments
排除标准
- •• The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
- •Having surgical therapy or undergoing orthodontic treatment.
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- •Pregnant and lactation females.
- •Smoking ˃ 10 cigarettes/day.
- •Patients with poor oral hygiene.
- •Any known allergies
研究组 & 干预措施
hyaluronic acid
Experimental
Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after.
干预措施: Hyaluronic acid (Drug)
scaling and root planing
Active Comparator
scaling and root planing using ultrasonic scaler and hand instruments.
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Clinical attachment level gain
时间窗: 3 months
Clinical attachment gain by using UNC15 Periodontal probe/ numerical data
次要结局
- Pocket depth reduction(3 moths)
- Bleeding on probing(3 months)
- Gingival Recession(3 months)
- Radiographic Evaluation(3 months)
研究者
Reem Mohammed Ahmed Al-abbadi
dentist
Cairo University
研究点 (1)
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