Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Early healing index (inflammation phase)
研究概览
简要总结
The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes.
Participants will be asked to take either
- 2 g of amoxicillin + clavulanate, or
- placebo, one hour prior to surgery and without knowing what medicine they took.
Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in need of surgical crown lengthening operation in one/two teeth
排除标准
- •systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus
- •antibiotic or anti-inflammatory drug use in the last 3 months
- •pregnancy/lactation
- •chronic steroid, immunosuppressant or NSAD use
- •age <18 years
- •positive bleeding on probing at the surgical site and/or active periodontal disease
- •<2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation)
- •Miller 2 or 3 tooth mobility
- •penicillin allergy
- •unwilling to participate
研究组 & 干预措施
antibiotic prophylaxis
per os 2 g augmentin one hour prior to surgery
干预措施: Surgical crown lengthening (Procedure)
antibiotic prophylaxis
per os 2 g augmentin one hour prior to surgery
干预措施: Augmentin (Drug)
placebo control
per os placebo one hour prior to surgery
干预措施: Surgical crown lengthening (Procedure)
结局指标
主要结局
Early healing index (inflammation phase)
时间窗: at 3 days
Scores are given as specified below (Hamzani et al. 2018) Bleeding (spontaneous or provoked) Yes: 0; No: 1 Granulation tissue Yes: 0; No: 1 Hematoma Yes: 0; No: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Incision margins Incomplete flap closure/fibrin clot/partial or complete necrosis: 0; Complete closure/fine fibrin line: 1 Suppuration Yes: 0; No: 1 Edema VAS 6-10: 0; VAS 1-5: 1 Pain VAS 6-10: 0; VAS 1-5: 1
Early healing index (proliferation phase)
时间窗: at 10 days
Scores are given as specified below (Hamzani et al. 2018) Re-epithelization Partial: 0; Complete: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Suppuration Yes: 0; No: 1 Pain VAS 6-10: 0; VAS 1-5: 1
Early healing index (remodeling phase)
时间窗: at 6 weeks
Scores are given as specified below (Hamzani et al. 2018) Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Pain VAS 6-10: 0; VAS 1-5: 1
次要结局
未报告次要终点
研究者
Mustafa YILMAZ
Assistant Professor
Biruni University