Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT)
研究概览
简要总结
This study is intended primarily to compare the effects of two Class II correction appliances, namely Twin block and Myobrace appliances, on pharyngeal airway dimensions during the treatment of class II division 1 adolescent patients, also evaluates three dimensional (3D) changes of pharyngeal airway including: minimum cross-sectional area and volume using Cone Beam Computed Tomography (CBCT), skeletal, dentoalveolar, and soft tissue changes using cephalometric analysis, and three dimensional (3D) soft tissue changes using facial scans. The hypothesis being a consideration of no significant difference in the changes of pharyngeal airway and facial dimensions in skeletal class II patients before and after treatment with Twin block and Myobrace.
详细描述
This study is a multicenter randomized comparative clinical trial, employing non-stratified randomization in two-parallel arms with equal allocation ratio of 1:1. Patients will be recruited from Orthodontic Clinic at the College of Dentistry, University of Kufa, and from specialized dental centers affiliated to the Iraqi Ministry of Health, in addition to some private clinics. Initially, the patients will be assessed for eligibility to participate in the study according to the inclusion criteria. Then, the parents will be informed verbally about the purpose of the study and will be provided with the informed consent form to be signed. Patients will be treated using two types of functional appliances ( Twin Block and Myobrace) for six months. Regular follow-ups will be conducted during the course of the treatment and progress will be charted out at 4-weeks intervals.
Participants will be randomly assigned to one of two groups, each receiving one of the specified treatments over a six-month period.
Group I: Twin Block Appliance
- Design: Comprises maxillary and mandibular components anchored using Adams' clasps on the first permanent molars and lower first premolars. A passive labial bow will be incorporated into the upper arch, with ball-end clasps for additional retention.
- Bite Registration: Achieved through a symmetric protrusive bite using modeling wax, ensuring an edge-to-edge incisal relationship with a 2-3 mm bite opening between central incisors.
- Inclined Bite Blocks: Positioned at a 70° angle to facilitate forward mandibular displacement.
- Patient Instructions: Continuous wear is mandated (24 hours/day), excluding periods of oral hygiene. Adjustments using self-cured acrylic may be made for further mandibular advancement.
Group II: Myobrace Appliance
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 (Participant, Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 10-14 years, at growth spurt phase as determined by the cervical vertebrae maturation stage (C3- C4 ) assessed by lateral cephalograms.
- •Skeletal relationship: skeletal class II (ANB angle > 4°) with normal maxilla (SNA angle 78°- 84°), and retrognathic mandible (SNB angle < 77 °).
- •Dental relationship: Moderate to severe dental class II division 1 malocclusion with overjet 6 -10 mm.
- •Convex facial profile.
- •Well aligned/mild crowding (< 4 mm) of dental arches.
- •Good to fair oral hygiene status as based on a simplified oral hygiene index (OHI-S).
- •Normal or decreased lower facial height (SN-MP angle ≤ 32).
排除标准
- •Previous orthodontic/orthopedic treatment.
- •Patients with dental open bite
- •Patients with obvious facial asymmetry.
- •Patients with orofacial cleft.
- •Previous extractions.
- •Presence of mandibular shifts.
研究组 & 干预措施
Twin block appliance
It consists of maxillary and mandibular appliances that fit tightly against the teeth, alveolus, and adjacent supporting structures. Adams' clasps will be used bilaterally to anchor them to the first permanent molars and lower first premolars. A short passive labial bow will be added to the upper arch and ball end clasps to the interproximal areas of the lower arch for retention. The appliance will be fabricated after a symmetric protrusive bite registration using pink modeling wax sheets, in which the patients will rehearse many times before registration. The inclined bite blocks (ramps) will be at 70 which acts as a guiding mechanism for forward displacement of the mandible. The working bite will be taken with the incisors in an edge-to-edge relationship if possible and 2 to 3 mm bite opening between the central incisors. All the subjects will be instructed to wear the appliance 24 hours/day except for brushing. If further advancement
干预措施: Twin block (Device)
Myobrace appliance
The appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. This distance is used to determine the correct size using a special table. Once chosen and inserted in patient's mouth, upper canines, even if not yet erupted, must be in their slots, so that the dental mildines coincided with the appliance's midline. In the first week, the patients will be instructed to gradually increase the wearing time of the appliance during the daytime. By the start of the second week, the patients will be instructed to wear the appliance achieving at least 8 hours during sleeping. By the end of the first 4 weeks, the patients will wear the appliances minimum of 1- 2 hours during the day plus the overnig
干预措施: myobrace appliance (Device)
结局指标
主要结局
minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT)
时间窗: From enrollment to the end of treatment at 6 months
3D measurements of pharyngeal airway minimum cross-sectional (mm\^2) will be performed for all participants of both groups at two stages before treatment and at the end of the study using CBCT
次要结局
- three dimensional changes in the volume of the pharyngeal airway using CBCT(From enrollment to the end of treatment at 6 months)
- Skeletal changes using cephalometric analysis(From enrollment to the end of treatment at 6 months)
- Soft tissue changes using cephalometric analysis(From enrollment to the end of treatment at 6 months)
- Dentoalveolar changes using cephalometric analysis(From enrollment to the end of treatment at 6 months)
- Dental changes using study models(From enrollment to the end of treatment at 6 months)
- three dimentional soft tissue changes using facial scans(From enrollment to the end of treatment at 6 months)
研究者
Lubna Makki Hussein
Principal Investigator
University of Baghdad