Clinical and Histopathological Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Histopathological thermal damage zone
研究概览
简要总结
The aim of the RCT is to analyse clinical and histopathological particularities for excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser, CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding, the need for additional electrocoagulation or sutures and patient's postsurgical perception of pain, other postsurgical effects and use of analgesics.
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
- Single (Participant)
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
- •Clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa
- •Fibrous hyperplasia dimensions 0.5 to 2 cm
- •Patient understands and reads the German language
- •Written informed consent
排除标准
- •Untreated diabetes Typ II
- •Severe infectious disease (HIV, hepatitis)
- •Severe psychiatric disease
- •Immunosuppressive therapy
- •Anticoagulation
- •Pregnancy; a pregnancy test (Clearblue®) is performed in women of childbearing age
研究组 & 干预措施
Er:YAG laser
Excisional biopsy of fibrous hyperplasia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.
干预措施: Excisional biopsy with Er:YAG laser (Procedure)
CO2 laser
Excisional biopsy of fibrous hyperplasia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.
干预措施: Excisional biopsy with CO2 laser (Procedure)
Scalpel
Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).
干预措施: Excisional biopsy with scalpel (Procedure)
结局指标
主要结局
Histopathological thermal damage zone
时间窗: Three months
Biopsy specimens fixed in a 4% neutral-buffered formalin solution, embedded in paraffin, sectioned in slices of 5 μm, and stained with hematoxylin-eosin. Measurements of the thermal damage zone (in μm) on histopathological specimens by pathologist, blinded to the surgical method used. Measurements of the maximal and the minimal thermal damage zone on a representative section on both lateral edges of the fibrous hyperplasia.
次要结局
- Number of patients with other postoperative effects(Two weeks)
- Time of surgery(15 minutes)
- Postoperative Pain(Two weeks)
- Bleeding during surgery(15 minutes)