Effect of Diode Laser (940nm) on Total Relief of Dental Crowding and Pain Perception in Orthodontics: Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total relief of dental crowding
研究概览
简要总结
To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
详细描述
Objectives: To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
Design: Randomized clinical trial. Setting: orthodontic treatment from the Orthodontic postgraduate course at the CIEO University (CIEO), located in the city of Bogotá, Colombia Participants: 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent. Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements, with systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism) were excluded. , pregnant women, infants and patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
Intervention: group 1 irradiated with low power laser (940nm) and. Group 2: it was simulated that they were irradiated. The therapeutic laser was applied for a time of 10 seconds on the buccal surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at the gingival level and at the apical level in scanning mode, on the day of cementation of the appliance and subsequently every fifteen days for 3 months.
Main outcome measures: total relief of dental crowding measured through the little index in digital models and pain perception through the visual analog scale.
Randomization: Four patients were randomized with the randomized blocks technique.
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)
盲法说明
The patients participating in the clinical trial, the statistician, the students and the study operators who are going to measure Little's irregularity index will be blinded to the interventions, except the principal investigator.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages between 20 and 40 years
- •Male or female
- •All lower permanent teeth or at least 36 to 46
- •Little's irregularity index 3mm to 6mm
- •Without prior orthodontic treatment
- •Periodontally stable
- •Non-smokers
- •Voluntarily agreed to participate in the study by signing the informed consent
排除标准
- •Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements
- •Systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism)
- •Pregnant women
- •Patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
结局指标
主要结局
Total relief of dental crowding
时间窗: 3 months
This was measured as the resolution of anterior crowding in the lower arch calculated by the difference of Little's irregularity index, the distance in millimeters between the contact points from mesial of the canine to mesial of the contralateral canine in the lower arch in the digitized models in each of the established times. Perfect alignment from the mesial aspect of the left canine to the mesial aspect of the right canine would theoretically have a score of 0, with greater crowding represented by greater displacement and thus a higher index score.
次要结局
- Pain perception(3 months)