Management of Skeletal Class III Malocclusion With Digital Bonded Reverse Twin Block in Mixed Dentition
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
研究概览
简要总结
The purpose of this study is to evaluate dentoalveolar & skeletal effects of digital bonded reverse twin block in treatment of skeletal class III malocclusion in mixed dentition.
Class III malocclusion presents significant management and prognostic challenges due to the complex interplay of factors in its etiology. Early diagnosis, planning of adequate therapeutic time and choice of devices to correct malocclusion are the essential keys to successful management of class III in all its forms. Functional appliances are commonly used for the treatment of skeletal class III malocclusion. The aim of this study is to evaluate dentoalveolar & skeletal effects of digital bonded reverse twin block (DBRTB) in treatment of skeletal class III malocclusion in mixed dentition. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The DBRTB will be designed as four occlusal blocks, two blocks for the upper arch, and two blocks for the lower arch. The upper blocks will be bonded to the anterior part of the maxillary arch, the lower blocks will be bonded to the posterior part of the mandibular arch. Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transfer transparent trays will be used to support the bonding procedure of the blocks. Oral Health Related Quality of Life (OHRQoL) assessments will be incorporated as an outcome measure in addressing and measuring clinically meaningful change.
详细描述
The study includes two groups: (Study design: non-randomized clinical trial)
- Group 1: control group untreated retrospective data of skeletal class III patients
- Group 2: patients treated with digital bonded reverse twin block (DBRTB) -Twenty one patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Digital Bonded Reverse Twin Block (DBRTB) to evaluate its dentoalveolar and skeletal effect
Bite registration:
The patient intraoral scan will be obtained using Medit i-700 intraoral scanner. The intraoral scan will be performed according to the constructor's instructions. The software interface of the intra-oral scanner allows the registration of two different maxillo-mandibular relationships (MMRs).
The first MMR scan will be registered in maximum intercuspation occlusion. The second scan will be registered in planned mandibular retrusion for DBRTB design.
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)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age (8-11) years (CVM stages 2-3)
- •Mild class III skeletal pattern (Wits appraisal = 0 to -8)
- •Mixed dentition
- •Mild to moderate reverse overjet (-1 to -4)
- •Overbite (1-5)
- •Average or below average maxillary mandibular plane angle and lower facial height
- •Mild incisors compensations
排除标准
- •Severe class III skeletal pattern
- •Long facial height
- •Bad oral hygiene
- •Systemic condition that may interfere with treatment
- •No premolars or deciduous molars
研究组 & 干预措施
Retrospective skeletal class III patients
Untreated
Growing patients with mild skeletal class III
Digital Bonded Reverse Twin Block
干预措施: Digital Bonded Reverse Twin Block (Device)
结局指标
主要结局
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
时间窗: 12 months
Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases
次要结局
- OHRQoL (Oral Health-related Quality of Life) assessments are being incorporated into clinical studies and trials to measure efficaciousness of treatment with the goal of improving care.(12 months)