A Randomized Clinical Trial on Upper Sequential Distalization With Temporary Anchorage Devices (TADs) and Two Aligner Systems
试验速览
- 阶段
- 不适用
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Achievement of molar class I
研究概览
简要总结
In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems. The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems.
详细描述
In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase. Also, the investigators are going to study another dental movements, pain level, aligner properties, oral hygiene, posterior root resorption, patient satisfaction, quality of life and efficiency of these systems.
The aligner systems that are going to be used are Invisalign System (Align Technology, San José, CA), Spark Aligners (Ormco, Glendora, CA), Quicksmile (Madrid, España) and ClearCorrect (Straumann, Austin, TX). To help achieve the molar movement there is going to be place a TAD (temporary anchorage device) between two teeth. Before starting the study, the patients will need some pretreatment records (radiographs, photographs, dental casts and intraoral scan) to make a diagnosis and confirm if the patient is suitable for the study.
The required sample will be 98 subjects, assuming a sample loss of 15% the required sample will be 115 subjects per group. Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study. Data normality will be examined with the Kolmogorov-Smirnov. Descriptive statistics of the different outcomes will be calculated for each group. Student's paired sample t-test will be used to analyze intragroup differences between T0 and T1. Intergroup comparison among different intervention groups will be performed using multiple analysis of variance (MANOVA), with Tukey's post-hoc test. The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age. The investigators will perform a binary logistic regression in order to assess the influence of confounding factor (clinical variables) on the primary outcome. All statistical analysis will be conducted using IBM SPSS 24.0 (SPSS Inc., Chicago, IL, USA) software with a 0.05 level of significance.
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
盲法说明
Patients recruited into the study who met the inclusion criteria will be assigned to group 1 Invisalign, group 2 Spark, group 3 Quicksmile or group 4 ClearCorrect. To generate the allocation sequence, a block randomization system with block sizes of 4 and a 1:1:1:1 allocation ratio will be applied using GraphPad online software. The allocation will be concealed from the orthodontist, investigator, and patient. When a patient was determined to be eligible, the orthodontist explained the clinical trial to them, and the patient signed the informed consent to participate. After the allocation of the interventions, neither the patient nor the orthodontist will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who needed orthodontic treatment with aligners in both jaws.
- •Adult patients (>18 years)
- •Full permanent dentition (excluding third molars)
- •Patients with non-surgical or non-extraction (excluding third molars) treatment
- •No active periodontal disease
- •Patients with class II molar relationship that needed molar distalization
排除标准
- •Patients with systemic diseases affecting bone metabolism or teeth or inflammatory diseases
- •Patients undergoing treatment with immunosuppressant or bisphosphonates
- •Patients undergoing chemo and radiotherapy
- •Patients with any other syndrome-associated orofacial deformation, cleft lip or palate
- •Pregnant women or non(or poor)-compliance patients with skeletal discrepancies
- •Patients with dental or skeletal crossbite that need 3 mm or more per side of expansion
研究组 & 干预措施
Invisalign
Patients treated with Invisalign aligners
干预措施: Orthodontic treatment with Invisalign system (Device)
Spark
Patients treated with Spark aligners
干预措施: Orthodontic treatment with Spark system (Device)
Quicksmile
Patients treated with Quicksmile aligners
干预措施: Orthodontic treatment with Quicksmile system (Device)
ClearCorrect
Patients treated with ClearCorrect aligners
干预措施: Orthodontic treatment with ClearCorrect system (Device)
结局指标
主要结局
Achievement of molar class I
时间窗: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Achievement of class I after distalization will be assessed with yes (=1) or no (=0). It will be considered class I when the mesiobuccal cusp of the upper first molar occludes with the mesiobuccal groove of the lower first molar when seeing models in occlusion with a discrepancy of 0.5 mm.
Predictability of upper molar distalization
时间窗: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Predictability of upper molar distalization will be assessed in mm comparing pre- and post-distalization 3D models. Pre-treatment 3D model (ModT0) will be superimposed with ideal end of distalization model (ClinT1) and real end of distalization models to see how much distalization has been achieved. The predictability will be the difference between the achieved and the expected amount of tooth movement and to quantify distalization measurements are going to be made in various views and teeth.
次要结局
- Individual tooth movement(Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months))
- Peri-implant mucosa inflammation(Time 0 (initial day of treatment), month 3 and month 6)
- Quantification of the number of appointments.(Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months))
- Periodontal mucosa health status - Gingival Index (GI)(Time 0 (initial day of treatment), month 3 and month 6)
- Periodontal mucosa health status - Papillary Bleeding Index (PBI)(Time 0 (initial day of treatment), month 3 and month 6)
- Quantification of changes in desinsertion time after 75 desinsertion cycles(Time 0 (initial day of treatment) and week 2)
- Orthodontically induced external apical root resorption (OIEARR)(Time 0 (initial day of treatment) and month 6)
- Quantification of the treatment and chair time.(Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months))
- Quantification of the direct and indirect costs.(Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months))
- TADs stability(Time 0 (initial day of treatment), month 3 and month 6)
- Quantification of changes in deformation after 75 desinsertion cycles(Time 0 (initial day of treatment) and week 2)
- Quantification of quality of life (OHIP-14sp)(Time 0 (initial day of treatment) and month 1)
- Quantification of the modulus of elasticity(Time 0 (initial day of treatment) and week 2)
- Quantification of changes in force after 75 desinsertion cycles(Time 0 (initial day of treatment) and week 2)
- Quantification of the aligner fit on the attachments(Time 0 (initial day of treatment) and week 2)
- Quantification of pain level(Week 3, week 7 and week 11.)
- Quantification of patient satisfaction (DSQ)(Time 0 (initial day of treatment) and month 1)
- Periodontal mucosa health status - Plaque Index (PI)(Time 0 (initial day of treatment), month 3 and month 6)