Low Power Laser in the Second Molar Tissue Repair and in the Postoperative of Mandibular Third Molar Surgery - Double Blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 主要终点
- Periodontal probing
研究概览
简要总结
The low-power laser provides the body with an improvement in the inflammatory response. Thus, the objective of this study is to evaluate two laser application protocols in 60 patients requiring surgical treatment for extraction of third molars included, without distinction of race or gender, aged between 16 and 40 years, coming from the Faculty of Dentistry Of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) , group 2 - intraoral irradiation with 660 nm laser at a dose of 30 J (30 mW, 30 J / cm 2) and group 3- control group, with application of placebo laser. At 3 and 7 days after surgery, the patients will be evaluated by two evaluators who will measure edema, trismus and pain. The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
详细描述
Knowing the ability of the low-power laser to provide the body with an improvement in inflammatory response, with consequent reduction of edema, minimizing painful symptoms and leading to biostimulation, laser therapy is presented as an alternative for processes that present an inflammatory reaction, Pain and need for tissue regeneration. The literature shows the efficacy of laser in the postoperative surgery for extraction of third molars. However, to date, there is no consensus on the best protocol to be used in these cases. Thus, the objective of this study will be to evaluate two laser application protocols. To this end, 60 patients will be selected who require surgical treatment for the extraction of third molars, regardless of race or gender, between the ages of 16 and 40, from the School of Dentistry of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2), group 2 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) and group 3 - control group, with application of placebo laser. At 3 and 7 days after surgery, patients will be evaluated by two evaluators who will measure edema, mouth opening (assessment of muscle spasm) and pain. To compare the data, we will use the analog pain scale (VAS), the method of Ustün et al. (2003), and the millimeter rule. The patient will also be questioned about possible postoperative problems, as well as the surgeon, who will classify the postoperative repair process according to Batinjan et al. (2013). The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Surgical procedures were always performed by the same surgeon and assistant, who were unaware of the surrogate group that belonged to the patient, as well as the patient himself. This randomization was performed involving numbers and envelopes, being only the investigator's knowledge.
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients, without surgical contraindications, requiring avulsion of the included third molars and / or impacted lower molars,
- •Teeth classified according to Winter (1926) as mesioangulated and according to Pell & Gregory (1933) as 1A to 2B.
- •Between the ages of 16 and 40
- •Who have agreed to participate in the research voluntarily, after knowing the risks and benefits, and signed the Informed Consent Term (TCLE)
排除标准
- •Patients with any systemic or local change that contraindicate the procedure,
- •Use of anti-inflammatories in the last 15 days,
- •Patients smokers or diabetics.
研究组 & 干预措施
Grupo III- Laser sham
Application of laser sham, the handpiece of the device will be positioned intraorally and activated. However, the tip of the applicator will be covered by an opaque material that prevents radiation from passing through.
干预措施: Grupo I- Lower laser fluency (Radiation)
Grupo I- Lower laser fluency
20 patients received 660 nm red laser diode laser therapy, 30 mW power and 10 J / cm2 fluency, in the immediate period after surgical period of the third molar third molar extraction / impacted by the intraoral region
干预措施: Grupo II- Greater laser fluency (Radiation)
Grupo I- Lower laser fluency
20 patients received 660 nm red laser diode laser therapy, 30 mW power and 10 J / cm2 fluency, in the immediate period after surgical period of the third molar third molar extraction / impacted by the intraoral region
干预措施: Grupo III- Laser sham (Radiation)
Grupo II- Greater laser fluency
20 patients received 660 nm red laser diode laser therapy, 30 mW power and 30J / cm2 fluency, in the immediate period after surgical of the third molar third molar extraction / impacted by the intraoral region
干预措施: Grupo I- Lower laser fluency (Radiation)
Grupo II- Greater laser fluency
20 patients received 660 nm red laser diode laser therapy, 30 mW power and 30J / cm2 fluency, in the immediate period after surgical of the third molar third molar extraction / impacted by the intraoral region
干预措施: Grupo III- Laser sham (Radiation)
Grupo III- Laser sham
Application of laser sham, the handpiece of the device will be positioned intraorally and activated. However, the tip of the applicator will be covered by an opaque material that prevents radiation from passing through.
干预措施: Grupo II- Greater laser fluency (Radiation)
结局指标
主要结局
Periodontal probing
时间窗: Initially carried out in one, three and six months
Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). For the investigator periodontal evaluation was performed based on the modified Montero \& Mazzaglia (2011) methodology, where the length of the clinical crown in the second distal molar region will be measured with a North Carolina-type probe (Hu-Friedy, Chicago, USA). According to this methodology, we will previously mold the occlusal of the second molar with a condensation silicone (Optosil Xantopren, Heraeus Kulzer, Hanau, Germany), which was used as a guide to standardize the location and height of the measurement. We will then measure at three points in the distal of the second molar: disto-lingual, mesio-distal and vestibular-distal.
次要结局
- Pain assessment(Evaluated immediately, two, four, six and eight hours after surgery. And with continuity for one, two, three and four days)
- Edema assessment(Initially carried out in three and seven days.)
- Trismus assessment(Initially carried out in three and seven days)
- Radiographic assessment(Assessment in one, three and six months)
研究者
Michelle Bianchi de Moraes
Professor Assistente Doutor - Departamento de Diagnóstico e Cirurgia - São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil.
Universidade Estadual Paulista Júlio de Mesquita Filho