Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition: a Longitudinal, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Long-term spontaneous alignment of anterior maxillary teeth
研究概览
简要总结
The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are:
- If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period.
- If there is a difference between the experimental group and the control group in regard to oral health related quality of life.
- If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group.
- If early maxillary expansion is more cost-effective than treatment in the permanent dentition.
To be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva.
Subjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted.
At the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life.
Researchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.
详细描述
The study will be conducted on consecutively included subjects referred to the centers and then randomized into either an experimental group or a control group.
To be able to evaluate the amount of anterior crowding before the lateral incisors have erupted, low-dose Cone Beam Computed Tomography-scans are used to measure the width of the unerupted laterals. The anterior crowding is calculated by comparing the width of the laterals with measurements of the distance between the mesial surfaces of the deciduous upper canines on study casts. The eligible subjects are then randomized to either experimental och control group.
The subjects in the experimental group will be treated with a maxillary expansion appliance with bands on the second deciduous molars and arms to the deciduous canines. A small preparation on the palatal surface of the deciduous canines is performed to facilitate bonding of the arms. The screw gives a expansion of 0,20 millimeter per activation. The arms are bonded to the deciduous canines with light curing composite and the bands are cemented on the etched second deciduous molar with glassionomer cement.
Then the subject and the parents are instructed to activate the appliance once a day (1/4 turn) for 2 weeks and thereafter every second day until adequate space for the lateral incisors is obtained and the first permanent molars are approaching scissor-bite.
The expansion can be paused for 7-8 months after 25-30 activations if the lateral incisors are not yet erupted and the permanent molars are going in scissor-bite to allow for their spontaneous correction. The expansion is then continued until adequate space for the lateral permanent incisors is achieved.
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 outcome assessor will do measurements on study models. The study models will be masked when it comes to treatment modality. Surveys will be masked.
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects without sucking habits
- •Permanent maxillary central incisors and first permanent molars fully erupted. DS1M
- •No severe crowding or protrusion in the lower arch considering the Leeway space and normal development of the arch.
- •Permanent first molar in normal transversal relation.
- •Crowding of the maxillary incisors with the lateral incisor just erupting ectopically or not yet emerged through the gingiva.
- •Crowding greater than or equal to 6 millimeters between the upper deciduous canines.
排除标准
- •Skeletal asymmetries, anomalies and syndromes.
- •Previous orthodontic treatment
结局指标
主要结局
Long-term spontaneous alignment of anterior maxillary teeth
时间窗: At the end of the observation period, an average of 5 years
The long-term spontaneous alignment of anterior maxillary teeth will be evaluated visually and measure on the digital study models.
次要结局
- Morphological changes in the upper and lower arches.(At the end of the observation period, an average of 5 years.)
- Impact on oral health related quality of life(At the end of the observation period, an average of 5 years.)
- Cost-effectiveness of early expansion treatment(At the end of the observation period, an average of 5 years.)
- Complications of expansion.(At the end of the observation period, an average of 5 years.)