Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
研究概览
简要总结
The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics.
The main questions it aims to answer are:
Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase?
Is there any difference between the two groups in the anchorage loss at the end of total treatment?
Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion.
Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.
详细描述
The aim of the study is to compare distalization of maxillary first and second molars achieved with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. All patients will be randomly assigned into two groups:
- Group I (AMDA®) consisting of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian.
- Group II (Spark®) consisting of patients that will be treated with clear aligners for both molar distalization and anterior teeth retraction.
Lateral cephalometric radiographs of the patients' heads and three-dimensional (3D) intraoral scans of the maxillary and mandibular arches will be taken:
- before treatment (T1),
- at the end of active distalization (T2), (active distalization will be completed, when first and second molars will achieve a full Class I molar relationship (not a super-Class I), and
- at the end of treatment (T3).
Cone Beam Computed Tomography (CBCT) dental scans will be taken in patients assigned to the AMDA group:
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
- None
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least half cusp bilateral Class II malocclusion between upper and lower first molars due to maxillary excess or maxillary protrusion or forward movement of the maxillary posterior teeth, where maxillary molar distalization is indicated.
- •Patients in the permanent dentition period of less than 30 years of age with second molars erupted at least one half.
- •Patients with good general health and healthy periodontium.
排除标准
- •Patients with Class II malocclusion between upper and lower first molars due to mandibular deficiency or mandibular retrusion.
- •Patients with less than half cusp bilateral Class II malocclusion between upper and lower first molars.
- •Patients with unilateral Class II malocclusion between upper and lower first molars.
- •Patients with cleft lip and palate or with other craniofacial syndromes.
- •Patients with missing, or congenital missing or supernumerary teeth.
- •Patients with full coverage molar restorations.
- •Patients with previous orthodontic treatment.
研究组 & 干预措施
AMDA® (Advanced Molar Distalization Appliance)
The AMDA arm consists of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian.
干预措施: Upper molar distalization (Procedure)
Spark®
The Spark® arm consists of patients that will be treated with clear aligners and elastics for both molar distalization and anterior teeth retraction.
干预措施: Upper molar distalization (Procedure)
结局指标
主要结局
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
时间窗: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars.
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
时间窗: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
时间窗: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars.
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
时间窗: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
次要结局
- Duration of active distalization phase(T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, at the end of distalization phase (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).)
- Duration of total treatment(T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.)
研究者
Katerina Samandara-Bouzani
Principal investigator
Aristotle University Of Thessaloniki