A Comparative Evaluation of Whole Maxillary Dentition Distalization Using Sliding Jig vs. Retraction Hooks Anchored by IZC Miniscrews: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of Molar Distalization.
研究概览
简要总结
This randomized controlled clinical trial aims to compare the clinical efficacy, efficiency, and biomechanical differences between two methods for total maxillary dentition distalization: (1) the use of a Sliding Jig and (2) the use of Retraction Hooks, both anchored by Infrazygomatic Crest (IZC) miniscrews. The study will assess rates of distalization, anchorage loss, dentoalveolar tipping, patient comfort, and treatment-associated side effects.
详细描述
Background and Rationale In non-extraction orthodontic treatment of Class II malocclusion or maxillary dentoalveolar protrusion, whole maxillary dentition distalization is a key treatment modality. The advent of temporary anchorage devices (TADs), specifically infrazygomatic crest (IZC) miniscrews, has revolutionized this approach by enabling predictable posterior translation of the entire maxillary arch without significant anchorage loss or reliance on patient compliance.
However, the biomechanical method for transferring force from the miniscrew to the dentition-whether through a sliding jig (continuous force via a rigid attachment) or separate retraction hooks (segmented force applied to individual teeth or groups)-may lead to clinically significant differences in movement type, efficiency, stability, and patient experience. No randomized clinical trial to date has directly compared these two popular clinical approaches.
This study will provide evidence-based recommendations for optimizing clinical mechanics in whole arch distalization protocols.
Objectives Primary Objective To compare the rate of maxillary first molar distalization (in mm/month) achieved using the sliding jig technique versus retraction hooks anchored by IZC miniscrews.
Secondary Objectives To assess the amount and type of tooth movement (tipping vs. translation) of the maxillary first molars and central incisors.
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
- None
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
- •The inclusion criteria will be the following: Adult patients with class II malocclusion (>14 years), present of all permanent teeth fully erupted, Bilateral Class II molar relationship skeletal malocclusion, moderate maxillary arch crowding (less than 5 mm) with maxillary protrusion, absence of craniofacial syndrome. and, except third molars
排除标准
- •The subjects having the following conditions will be excluded from the study (1) Patients with transverse dental or skeletal discrepancies. (2) Patients indicated for extraction treatment (except for third molars) or unilateral distalisation treatment (3) Patients with Vertical growth pattern, (4) Patients having periodontal disease, (5) Patients with previous orthodontic treatment.
研究组 & 干预措施
Sliding Jig
Description: Participants in this group will undergo whole maxillary dentition distalization using Sliding Jig mechanics anchored by infrazygomatic crest (IZC) miniscrews.
干预措施: Sliding jig (Device)
Retraction Hook
Description: Participants in this group will undergo whole maxillary dentition distalization using Retraction Hooks mechanics anchored by infrazygomatic crest (IZC) miniscrews.
干预措施: retraction hooks (Device)
结局指标
主要结局
Rate of Molar Distalization.
时间窗: From baseline (start of distalization) to the completion of distalization (an average of 5 months).
Measured on digital models (from intraoral scans) by comparing the 3D position of the maxillary first molar (mesial contact point) relative to the stable palatal rugae at T0 (pre-distalization) and T1 (after 4mm distalization achieved or 6 months).
Rate of maxillary first molar distalization
时间窗: From baseline (start of active distalization forces) to the completion of planned distalization (target: 4-6 mm) or at 6 months, whichever comes first.*
The linear distal movement of the maxillary first molar, measured via 3D superimposition of serial digital intraoral scans on the stable palatal rugae, divided by the active treatment time in months to yield a rate in mm/month.
次要结局
未报告次要终点
研究者
Dr. Nagi Alawdi
Researcher, Sana'a University
Sana'a University