Effect of Low-Level Laser Therapy on Stability During Retention Phase After Orthodontic Treatment: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incisor Irregularities Index
研究概览
简要总结
The biggest problem in the orthodontic process is the pain and the long duration of treatment, which is also generally divided into 2 phases, namely the orthodontic tooth movement (OTM) and the retention phase. In recent decades, low-level-laser therapy has gained attention because it is non-invasive, inexpensive, relieves pain and has no significant adverse effects. Low-level-laser therapy (LLLT) has been proved to effectively induce and accelerate the remodeling process of alveolar bone by increasing the number of osteoblasts and osteoclasts. Therefore, LLLT is widely used in OTM to accelerate tooth displacement, but there are few studies and limited evidence on the stability whether it can strengthen and shorten the retention stage to avoid relapse. Thus, the purpose of this study is to investigate the stability after orthodontic treatment by observing the substantial influence of low-level-laser as during retention phase.
Research Question(s)
-
Does the low-level laser treatment can enhance stability and shorten retention time after orthodontic treatment or not will be demonstrated through 3 aspects：
-
The Incisor Irregularities Index between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
-
The interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
-
The overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
Objective
General:
The goal of this study is to investigate the stability in retention phase after application of LLLT during leveling and alignment with fixed appliances.
Specific:
- To compare the Incisor Irregularities Index between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
- To compare the interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention To compare the overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
详细描述
This is a continuation study from the previous approved project entitle "The Effect of low level laser therapy on orthodontic tooth movement using conventional and self-ligating brackets in extractions cases: A randomised clinical trial and 3D evaluation via CBCT and digital dental model approaches" with ethical approval no ( USM/JEPeM/17070339). Previous studies used an in-vivo study, designed as randomised clinical trial for patients under treatment with fixed orthodontic brackets in Orthodontic Specialist Clinic at Hospital Universiti Sains Malaysia.
The current study was designed to observe the effect of laser irradiation (LLLT) during retention period at debond (0), 6 and 12 months of retention phases. The laser (LLLT dose) was applied only during active orthodontic treatment (levelling and alignment stage) in previous study. Patients will not receive any more doses of LLLT during retention phases at debond (0), 6 and 12 months.
All participants (control group and experimental group) from the previous studies will be included and enrolled in this current study after receiving the consent from patients. Among them, those who received LLLT in the previous study will be enrolled in the Retention Laser Group (LG) and those who did not receive LLLT will be in the Retention Control Group (CG) for the current study. The smaller the variation in tooth alignment between LG and CG, the better the retention stability.
In this current study, Little's Irregularity Index (LII), overjet, overbite, arch length, intermolar and intercuspid widths will be used as indicators for the stability assessment.
Study population The same participants from project entitle "The Effect of low level laser therapy on orthodontic tooth movement using conventional and self-ligating brackets in extractions cases: A randomised clinical trial and 3D evaluation via CBCT and digital dental model approaches" with ethical approval no (USM/JEPeM/17070339) treated at Specialist Orthodontic Clinic, Hospital Universiti Sains Malaysia will be recruited for this current study.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patient treated with laser and non-laser application during orthodontic treatment as in previous study
- •2.The patient presents with mild to moderate crowding malocclusion with extraction of all 1st premolars and using conventional brackets
- •3.The treatment of fixed appliances involving both arches
- •Patients wearing vacuum formed retainers.
- •Patients are compliance towards retainer wear with no history of retainer lost
- •All permanent teeth erupted except for third molars.
排除标准
- •1.Age less than 18 years old
- •2.Active caries and Periodontal disease
- •3.Use any long-term use of analgesics or drugs that affect the function of the central nervous system.
- •Non-compliance patients in term of wearing retainers
- •Withdrawal criteria:
- •1.Any patient who would like to withdraw from the experiment can do without their treatment being compromised.
- •2.Patients who do not comply with the retainer requirements during the retention phase will be considered an automatic withdrawal from the research and their data will not be accepted.
结局指标
主要结局
Incisor Irregularities Index
时间窗: 12 months
To compare the changes in the Incisor Irregularities Index between the laser and control group after the application of LLLT at debond (0), 6, and 12 months of retention.
Overjet and overbite
时间窗: 12 months
To compare the changes in the overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
The interarch dimension: intercanine width, intermolar width, interpremolar width, arch length
时间窗: 12 months
To compare the changes in the interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
次要结局
未报告次要终点
研究者
WANG YANPEI, MD
Principal Investigator
Universiti Sains Malaysia