The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in molar and canine relationship at T3 (effectiveness)
研究概览
简要总结
The investigators of this clinical trial aim to:
- Compare the effectiveness and efficiency of Clark's Twin Block Appliance (CTB) vs Carriere Motion Appliance (CMA) in correcting Class II malocclusion when used in post-pubertal older adolescents, in terms of skeletal and dental change.
- Evaluate potential negative oral health-related quality of life (OHRQoL) impacts during the active treatment phase with either CTB or CMA in post-pubertal adolescents.
- Investigate the impact of Class II malocclusion on oral health-related quality of life (OHRQoL) in post-pubertal adolescents.
Class II division 1 malocclusion is a dental condition where the upper teeth protrude significantly over the lower teeth. It is a common type of malocclusion observed in orthodontic practice, accounting for approximately 20-25% globally. Correcting Class II malocclusion in growing patients using functional appliances and Class II correctors is relatively predictable.
In Ireland and the United Kingdom, the Clark's Twin Block (CTB) is the most commonly used functional appliance. The CTB consists of two components: one for the upper teeth and one for the lower teeth. These components are engineered to position the lower jaw forward, thereby promoting the desired dentoskeletal changes (moving the upper teeth back and lower forward). Another device used for Class II correction is the Carriere Motion Appliance (CMA). The CMA is gaining popularity as a treatment option for Class II malocclusion, inducing dental changes similar to those achieved with a CTB. However, uncertainty persists regarding the effectiveness of these appliances in older adolescents in the post-pubertal growth phase (aged approximately 14.5 years or above).
Additionally, although both CTB and CMA are effective in growing patients in correcting dental and skeletal discrepancies, they may influence daily activities, comfort, and psychological aspects, which often results in poor compliance. Poor adherence to orthodontic treatment, whether with fixed or removable appliances, can lead to higher rates of treatment failure.
详细描述
Introduction:
Multiple treatment approaches are available to address the Class II byccal segment relationship characteristic of this type of malocclusion. However, the treatment approach depends on various factors, with chronological and skeletal age being pivotal. Typically, patients present with an underlying Class II skeletal pattern characterised by mandibular retrusion.
In growing patients, treatment often involves growth-dependent strategies, such as functional appliances or other Class II correctors. While these approaches primarily produce dentoalveolar effects, with less than one-third of the correction achieved by functional appliances attributable to skeletal changes, understanding the distinction between skeletal and dentoalveolar impacts is crucial. This differentiation informs treatment choice by highlighting the varying degrees to which these methods can achieve skeletal versus dental corrections, essential for tailoring patient-specific plans.
A continuing discussion exists regarding the ability of functional appliances, whether removable or fixed, to provide effective short- and long-term stimulation of mandibular growth. While this discussion endures, it is widely recognised that the majority of correction achieved with these appliances tends to be dentoalveolar rather than skeletal in nature, with only a modest proportion attributable to true mandibular advancement. Furthermore, these dentoalveolar effects are not exclusive to functional appliances, as similar outcomes have been documented with alternative Class II correctors such as the Carriere Motion Appliance, as detailed in subsequent studies.
Some researchers propose that functional appliances yield favourable outcomes by promoting mandibular growth, either through increased mandibular length or condylar growth. Conversely, other studies contend that the extent of these skeletal effects is limited. Consequently, substantial evidence indicates that dentoalveolar changes resulting from functional appliance treatment exceed the skeletal changes.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of either patient or clinician will not be possible due to the nature of intervention. The trial will be single-blind, blinding will be ensured at the data collection and analysis stages in which the researchers (investigators) and statistician (outcome assessor) will be blinded to the intervention by coding all dental study casts and lateral cephalograms. The final dental study casts, lateral cephalograms and photographs will be taken (at T3) after removal of CMA and CTB so the researchers do not know which group the patients were in.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females aged 14 ½ -16 years from the HSE waiting list,
- •Cervical Vertebral Maturation (CVM) stage ≥5,
- •a mild-moderate skeletal II pattern,
- •normodivergent with average maxillomandibular planes angle (MMPA: 27±4 degrees),
- •Class II division 1 incisor relationship,
- •Class II molar relationship of ≥1/2 unit bilaterally,
- •overjet of ≥7 mm,
- •≤5mm of dental crowding in both arches and
- •fluent English speaker.
排除标准
- •have/had cleft lip or palate or craniofacial syndrome,
- •hypodontia,
- •gross mandibular asymmetry,
- •a medically diagnosed growth excess or deficiency,
- •not dentally fit or
- •had previously received orthodontic treatment.
结局指标
主要结局
Change in molar and canine relationship at T3 (effectiveness)
时间窗: T3: 9 months
The primary outcome measure (change in molar and canine relationship) will be calculated at T3. This will be calculated by measuring the difference from T0 to T3 in the horizontal plane (in mm); * from the cusp tip of maxillary canine relative to the distal contact point of the opposing mandibular canine (change in canine relationship) and * from the mesiobuccal cusp of maxillary first molar relative to the buccal groove of mandibular first molar (change in molar relationship). All the measurements will be performed on dental study casts (taken at T0 and T3) articulated in maximum intercuspation position (MIP) using a vernier calliper. Measurements from right and left sides will be taken. Change in the canine and molar relationship will be calculated as the difference from T0 to T3.
次要结局
- Impact of Class II correction on oral health-related quality of life (OHRQoL) based on the Malocclusion Impact Questionnaire (MIQ) scores at T0 and T4(T0: Baseline; T4: 42 weeks)
- Change in molar and canine relationship at T2 (efficiency)(T2: 18 weeks)
- Dentoskeletal cephalometric changes at T3(T3: 9 months)
- Impact of treatment on daily life based on the Orthodontic Treatment Impact Questionnaire (OTIQ) scores at T1 and T3(T1: 2 weeks; T3: 9 months)
- Impact of Class II correction on oral health-related quality of life (OHRQoL) based on the Child Oral Health Impact Profile (COHIP-19) scores at T0 and T4(T0: Baseline; T4: 42 weeks)
研究者
Aslam Alkadhimi
PhD researcher/Consultant Orthodontist
University of Dublin, Trinity College