Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Assessment the level of bone regeneration according to Radiographic bone height (RBH)
研究概览
简要总结
A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.
详细描述
A single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. The lower third molars will be extracted in 60 patients. There will be 2 groups. The number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. In the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). Postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. The epithelization will be assessed after 7, 10, 14 days. The bone regeneration will be assessed by cone beam computed tomography (KAVO, ORTHOPANTOMOGRAPH ОР 3D, type: РСХ-1; registration № РЗН 2020/10586) after 1, 3, 6 months. The radiation exposure will not exceed the permissible limits. Biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. The Shapiro-Wilk test will be applied to check the normality of variable distribu- tion. Qualitative variables will be analyzed by Pearson's chi-squared test. Quantitative variables (normal distribution of variable) will be analyzed by Students t-test, non-normal distribution of variables will be analyzed by Mann-Whitney U test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of written informed consent of the patient to participate in a study
- •Age from 25 to 50 years old
- •Indications for impacted third molar extraction
- •Patients who are medically stable
- •Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)
排除标准
- •Refusal of the patient from further participation in the study
- •Pregnancy diagnosed after the inclusion into the trial
- •Non-compliance by the patient with postoperative recommendations
- •Absence of a lower second molar
研究组 & 干预措施
Group with impacted third molar, extracted by cutting and rotary tools
The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction. Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities.
干预措施: Third molar extraction by cutting and rotary tools (Procedure)
Group with impacted third molar, extracted by erbium laser 2.94 nm
The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction.Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities.
干预措施: Third molar extraction by erbium laser with wavelength 2.94 nm (Procedure)
结局指标
主要结局
Assessment the level of bone regeneration according to Radiographic bone height (RBH)
时间窗: Days 180 after extraction
Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar. (Radiographic bone height (RBH)- is the distance between root apex of the distal root and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket, it will be measured on the cone beam computed tomography)
次要结局
- OPG (osteoprotegerin)(before surgery, after surgery, 3;7 days)
- Fibroblast growth factor-b (FGF-b)(before surgery, after surgery, 3;7 days)
- C-reactive protein (CRP)(before surgery, after surgery, 3;7 days)
- IgA(before surgery, after surgery, 3;7 days)
- IgG(before surgery, after surgery, 3;7 days)
- Vascular endothelial growth factor (VEGF)(before surgery, after surgery, 3;7 days)
- Radiographic bone height (RBH)(3;6 months)
- Radiographic infrabony defect (RID)(3;6 months)
- Post-operative pain(1;3;5;7;10 days)
- Post-operative oedema(1;3;5;7;10 days)
- Soft tissue epithelization(7;10;14)
- Trismus(1;3;5;7;10 days)
- sRANKL (soluble receptor activator of nuclear factor-κB ligand)(before surgery, after surgery, 3;7 days)
- IgM(before surgery, after surgery, 3;7 days)