Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration of Dental Crowding Cases Treated With Clear Aligners: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Little's Index of Irregularity
研究概览
简要总结
Patients with moderate mandibular anterior crowding will be treated in this study. The efficacy of micro-osteoperforations technique by special drill in accelerating orthodontic tooth movement during clear aligners therapy will be assessed along with patient's pain and satisfaction.
There are two groups:
- a group of patients in which participants will be received treatment with the traditional clear aligners technique in addition to a micro-osteoperforations technique.
- a group of patients in which participants will be received treatment with the traditional clear aligners technique alone
详细描述
Dental crowding is one of the most common orthodontic problems in adults as it was found that 80% of adults had crowding in the lower incisors area.
Although many adults need orthodontic treatment, they do not like and sometimes refuse to apply fixed orthodontic devices, so the emergence of Clear Aligners Technique (CAT) where the aesthetic aspect is one of the most important characteristics of this technique which can alleviate the response and anxiety of adult patients related to orthodontic treatment, its approach relies on the use of a series of clear aligners that slowly move each tooth into the desired position.
But the strict protocol that requires wearing each aligner 22 hours a day leads to poor patient compliance with it during the treatment period, so many clinical and laboratory attempts have been made to find different methods that achieve faster results and reduce the extent of orthodontic treatment, and among all the previous methods, the surgical approach is the most clinically used and the most tested with known expectations and stable results.
Although these surgical methods have proven effective, they are considered aggressive in nature as they require lifting of full-thickness buccal and lingual flaps with extensive removal of the buccal and lingual cortical bone, in addition to the fact that they may face rejection of the patient due to anxiety and fear of pain and undergo surgery, patients are usually not open toward ideas involving surgery unless it is the only option to obtain a good bite.
Hence, the interest has increased dramatically in recent years to develop conservative surgical techniques that provide similar clinical efficacy with minimal trauma and greater acceptance by patients. One of these techniques is the micro-osteoperforations technique, which is ideal for adult patients who have limited time and wish to finish their treatment as quickly as possible.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completion of permanent dentition (except third molars)
- •Moderate crowding (4-6 mm according to Little's index)
- •Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
- •Number of aligners ≥ 8 aligners.
排除标准
- •• Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
- •Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
- •Patients had previous orthodontic treatments
- •Poor oral hygiene or concurrent periodontal disease
结局指标
主要结局
Change in Little's Index of Irregularity
时间窗: T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after 5 months when Little's Index of Irregularity less than 1 mm and final aligner does not apply any pressure
The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Overall treatment Time
时间窗: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,
the overall time required to complete the treatment was calculated by calculating the number of days between (To) and (T3).
次要结局
- Satisfaction through acceptability of the procedure(After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,])
- Change in the levels of pain(4 ,12,24,48 hours following the onset of orthodontic treatment)
- Satisfaction with the ease of the procedure(After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,)
- Satisfaction using VAS(After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it)
- Satisfaction through recommending the procedure(After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth)