Efficacy of Skeletally Anchored Modified Leaf Expander Versus Modified Conventional Hyrax in Maxillary Molar Distalization: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Arch length
研究概览
简要总结
Background:
Distalization in orthodontics is one of conservative treatment modalities that result in gaining space especially in dental orthodontic cases of class ΙΙ molar relationship.
Aim:
This study aimed to compare the distalization effects of the skeletally anchored modified Leaf Expander versus the skeletally anchored modified conventional Hyrax Expander.
Patients and Methods:
Thirty patients (15-18 years) requiring maxillary molar distalization were randomly allocated into two groups (n = 15 each). Group 1 received the modified skeletally anchored self-activated Leaf Expander, and Group 2 received the modified skeletally anchored conventional Hyrax Expander. Pre- and post-distalization lateral cephalometric radiographs and digital dental models were analyzed for skeletal, dental, and arch dimensional changes. Treatment duration and adverse events were also recorded. Statistical analysis included paired t-tests and independent t-tests, with Bonferroni correction (α = 0.0045) applied for multiple comparisons. Effect sizes (Cohen's d) were calculated to assess clinical relevance.
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详细描述
Study setting and populations:
This prospective study included 30 patients consecutively enrolled and treated at the dental clinics, Orthodontic Department, Faculty of Dentistry, Tanta University, Egypt. Patients were aged between 15 and 18 years. All patients underwent maxillary molar distalization using one of two appliances.
Groups' randomization The patients involved in the study groups were randomly distributed through a simple online-generated randomization plan using online software found at the website http://www.graphpad.com/quickcalcs/index. cfm. The allocation ratio is 1:1.
- Group 1: Patients treated with the modified skeletally supported self-activated Leaf expander as a distalization appliance (7 males, 8 females).
- Group 2: Patients treated with the modified skeletally supported conventional HYREX expander as a distalization appliance (6 males, 9 females).
Inclusion Criteria
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)
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Class II molar relation.
- •Patients aged between 15 and 18 years.
- •Overjet less than 6 mm
- •ANB angle between 5° and 7°.
- •Non-extraction treatment plan with molar distalization.
- •Horizontal or normal growth pattern with symmetrical, balanced facial appearance.
- •Minimal crowding in the mandibular arch.
排除标准
- •Congenitally missing teeth
- •Congenital anomalies
- •Systemic diseases
- •Previous orthodontic treatment
研究组 & 干预措施
skeletally anchored Modified Leaf Expander
The Leaf Expander (Leaf Expander®, Leone SpA, Sesto Fiorentino, Florence, Italy) resembles a rapid palatal expander but incorporates Nickel Titanium MEMORIA leaf springs that provide continuous force. It consists of two body parts connected by rods over which the leaf springs slide. The springs are held compressed by staples on each side of the body parts. The superelastic nickel-titanium leaf springs deliver a controlled, continuous force once the staples are removed. Two types of Leaf Expanders are available, delivering either 450 or 900 grams of force; the 450-gram/ 6 mm in length version was used in this study.
干预措施: skeletally anchored Modified Leaf Expander (Device)
Skeletally anchored inverted hyrax
Fabrication of the Modified Palatally Anchored Expander Appliance
The positions of the screws for skeletal anchorage were determined on the model within a safe square on the anterior palatal area. Four lines were drawn (9):
- The first line, 8 mm distal to the incisive papilla, marked the anterior boundary.
- The second line, parallel to the first, passed through the distal surfaces of the second premolars to mark the posterior boundary.
- Two additional lines, each 8 mm lateral to the median palatal raphe, were drawn perpendicular to the first two lines.
干预措施: skeletally anchored Modified Leaf Expander (Device)
结局指标
主要结局
Arch length
时间窗: six months
Arch length in millimetres
Inter-canine width
时间窗: six months
Inter-canine width in millimetres
Inter-first premolar width
时间窗: six months
Inter-first premolar width in millimetres
Inter-second premolar width
时间窗: six months
Inter-second premolar width in millimetres
Inter-first molar width
时间窗: six months
Inter-first molar width in millimetres.
次要结局
- SNA angle(six months)
- SNB angle(six months)
- ANB angle(six months)
- FH-MP angle(six months)
- overjet(six months)
- U1/PP(six months)
- L1/MP(six months)
- interincisal angle(six months)
研究者
Mahmoud M. Fathy Aboelmahasen
Associate professor, Department of orthodontics - Faculty of Dental medicine (Boys, Cairo) - Al-Azhar University
Al-Azhar University