Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sagittal and vertical relationship by cephalometric radiograph.
研究概览
简要总结
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
- •Presence of permanent first molar with lower anterior teeth to retain the appliance.
- •Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
- •b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -
- •Prescence of unilateral or bilateral posterior crossbite.
- •Mild to moderate anterior crowding.
- •Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
排除标准
- •Patients with cleft lip and palate and/or craniofacial anomalies.
- •History of previous orthopedic and/or orthodontic treatment.
- •Presence of uncontrolled systemic disease or medically compromised status.
- •Uncooperative patient/parents.
研究组 & 干预措施
3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
干预措施: 3D printed Reverse Twin Block appliance (Device)
Conventional Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
干预措施: Conventional Reverse Twin Block appliance (Device)
结局指标
主要结局
Sagittal and vertical relationship by cephalometric radiograph.
时间窗: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
Skeletal changes (SNA, SNB, ANB, Wits appraisal, SN-Pog angle TAFH, TPFH, mandibular plane angle, facial plane angle, facial taper angle, facial axis angle, maxillary convexity, saddle angle).
Changes in sagittal relation using lateral cephalometric radiograph.
时间窗: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle
次要结局
- Transverse relationship by Study model(T0 baseline records T1 after 3 months T2 after 6 months)
研究者
Linda Basim
principal investigator
University of Baghdad