Bonded, Cemented or Removable Orthodontic Approaches to Correct Deep Bite in Mixed Dentition Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Maxillary dental arch length total
研究概览
简要总结
A deep bite is a bite where the upper front teeth cover almost all, if not all the lower front teeth.
Currently there is no clarity which of the available treatment approaches is better when these patients still have some baby (deciduous) teeth in their mouths.
This study will compare the results of four ways to manage this problem:
- Delay treatment until all permanent teeth are erupted,
- Temporary glue some brackets to the upper front teeth and correct the problem with orthodontic wires,
- Temporary glue some dental material in the back of the front teeth to allow the back teeth to erupt.
The amount of improvement (increased exposure of lower front teeth when biting) will be compared between the four treatment options.
The reason there is a no treatment group is because a slight improvement of the deep bite happens naturally in some cases. In this case delay of treatment is not a major concern as this bite type can be managed later during permanent dentition.
详细描述
Purpose: Deep bite, an increase from the normal overbite, is a problem that can be caused by a dentoalveolar and/or skeletal origin, and it is more common in class II malocclusion patients. Among children, the prevalence has been reported to range from 3 to 39%. This large variance can be explained by factors such as diagnosis criteria, sex, and ethnic group. Even though the stability and relapse of deep bite treatment have been previously discussed on permanent dentition, there is a lack of studies investigating their management during mixed dentition. Hence the goal of this clinical trial is to assess if any of the currently available approaches is more efficient considering factors such as costs, number of appointments, complications and patient's experience.
Hypothesis: The investigators hypothesized that the three active treatment approaches (bonded vs. cemented vs. removable) would produce similar dentoalveolar, skeletal and functional improvements. Those improvements would be larger than those observed on untreated children.
Justification: There is a lack of evidence regarding what early treatment approach for the deep bite is more effective, produces fewer side effects, and is more comfortable for patients. No randomized controlled trial evaluating the effectiveness of deep bite treatment during the mixed dentition has been identified. Early intervention may simplify future comprehensive orthodontic treatment. Moderate to severe deep bite cases could affect sagittal mandibular growth.
Objectives: This study aims to evaluate the effectiveness of two deep bite orthodontic treatments among children in the mixed dentition phase. Additionally, treatment duration, quality of life changes and complications of the different performed interventions will be assessed.
Research Method/Procedures: This study will be a stratified, parallel randomized controlled, single-blinded, with an allocation ratio of 1:1:1. The sample will be composed by children in mixed dentition (7-11 year olds), referred or self-referred to the orthodontic clinic at the University of Alberta (Edmonton, Alberta, Canada). The inclusion criteria will be: presence of moderate to severe deep bite (overbite >5.0 mm), fully erupted maxillary and mandibular incisors, as well as first permanent molars, no missing permanent incisors and molars, no clinically noticeable craniofacial syndromes and no clear need for immediate intervention to manage severe sagittal, transversal or vertical malocclusions. The participants will be divided into three groups:
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 (Outcomes Assessor)
盲法说明
The analyses will be blinded regarding treatment received and time.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of moderate to severe deep bite (overbite, >5.0 mm);
- •fully erupted maxillary and mandibular incisors, as well as first permanent molars.
排除标准
- •missing permanent incisors and molars;
- •clinically noticeable craniofacial syndromes;
- •need for immediate intervention to assess severe sagittal, transversal or vertical malocclusions.
结局指标
主要结局
Maxillary dental arch length total
时间窗: Before (T0) and after treatment (T1) (no more than 12 months).
Measurement of the total maxillary dental arch length, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.
Cephalometric analysis
时间窗: Before (T0) and after treatment (T1) (no more than 12 months).
Cephalometric measures, including sagittal interdental, maxillary and mandibular dentoalveolar measurements, will be collected for each participant. All these measurements will be combined on a final evaluation of craniofacial changes. Conventional 2-D Lateral cephalograms will be taken from all patients before treatment (T0) and at the end of the active intervention (T1). A trained and calibrated orthodontist, previously calibrated will perform the measurements.
Measurement of overjet and overbite
时间窗: Before (T0) and after treatment (T1) (no more than 12 months).
Measurement of overjet and overbite in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist.Obtained from digital bite models.
Arch length to incised edge
时间窗: Before (T0) and after treatment (T1) (no more than 12 months).
Measurement of the arch length to incisal edge, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.
Transverse maxillary molar distance
时间窗: Before (T0) and after treatment (T1) (no more than 12 months).
Measurement of the transverse maxillary molar distance, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.
Elimination of the moderate to severe anterior deep bite
时间窗: The success rate was assessed by comparing study models from before (T0) and after treatment (T1)(no more than 12 months).
The success in overbite correction (yes/no) will be defined as the complete dissolution of deep bite, with an overbite 3mm.
次要结局
- Compliance in the removable appliance group(12 months)
- Treatment duration in months(correction of deep bite up to a maximum of 12 months)
- Quality of life measurement(Before (T0) and after treatment (T1) (no more than 12 months).)
- Breakages(12 months)
- Emergency appointments(12 months)
- Additional appointments(12 months)