Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression in Lesions Refractory to Endodontic Treatment: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- quantification of IL-8
研究概览
简要总结
This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions.
详细描述
- Thorough medical and dental history for the eligible patients
- Thorough intraoral and extraoral diagnosis
- Local anesthesia
- Isolation and removal of any previous filling or restoration
- Removal of old gutta percha and establish patency to the full working length.
- 1st sample: will be collected using 3 sterile paper points
- Chemo-mechanical preparation.
- 2nd sample collection
• Laser group: The canals will be irradiated with a high-power diode laser, with wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter.
• Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation, but not activated.
- 3rd sample collection
- A piece of dry cotton will be placed in the access cavity, and then will be sealed with glass ionomer filling material
- 2nd visit: 1 week later, 4th sample collection then Obturation
- Number of visits & follow up period: Two visits
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected.
- •Teeth with straight root canals.
- •No contributory medical history.
- •No previous administration of analgesics and/or antibiotics within the previous 2 weeks.
排除标准
- •Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
- •Teeth with curved roots.
- •Swelling or sinus tract.
- •Mutilated teeth that interfere with proper isolation and seal between visits.
- •Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm.
- •Subjects with uncontrolled diabetes or debilitating diseases.
- •Pregnant or nursing females.
- •Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
结局指标
主要结局
quantification of IL-8
时间窗: one week
\- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.
次要结局
- Postoperative pain(6, 12, 24 hours and 7 days)
研究者
Dina Ahmed Morsy
lecturer in endodontic department, Cairo university
Cairo University