NCT04542486已完成不适用
Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain VAS
研究概览
简要总结
Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.
详细描述
In the control group:
- Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
- The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
- No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing
In the intervention group:
- Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
- Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
- No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anterior region (minimum of four teeth at each surgical site)
- •Age range (18-45) years old
- •Plaque-induced inflammatory gingival enlargement
- •Altered passive eruption
- •No clinical attachment loss
- •Systemically healthy individuals
排除标准
- •Gingival enlargement due to any systemic predisposing factors
- •Pregnancy and/or lactation
- •Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
- •Acute or untreated periodontitis
- •Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)
结局指标
主要结局
Pain VAS
时间窗: 7 days
Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.
次要结局
- Bleeding(From 3-5 days)
- Epithelization(14 days.)
- Tissue colour(6 weeks.)
- Surgical time(During surgical procedure itself.)
研究者
Mai Mohamed Sameh
Principal Investigator
Cairo University
研究点 (1)
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