Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in skeletal cephalometric measurements
研究概览
简要总结
The purpose of this study is to evaluate the skeletal, dentoalveolar & soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. Skeletal class III discrepancy has been a therapeutic challenge due to the fact that its therapeutic management seeks not only the correction of the malocclusion but also the aesthetic component of the patient which is affected according to the severity of the discrepancy. 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. Removable aesthetic appliance therapy as clear aligner becomes an increasingly common addition to the orthodontic armamentarium. It offers certain advantages over traditional appliance orthodontic treatments; these include fewer clinical emergencies and improved aesthetics, comfort, oral hygiene, periodontal health, and lack of soft tissue irritation. The aim of this study is to evaluate the skeletal, dentoalveolar & soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement. 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
. Fifteen patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Functional Clear Aligner to evaluate its skeletal, dentoalveolar & soft tissue effects.
Bite registration: The patient 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 Aesthetic functional appliance design. Bite registration will be done with the mandible in the most retruded position with an inter- incisal clearance of 2 mm and a clearance of 6 mm in the posterior segment.
To obtain an optimal and reproducible MMR scan in mandibular retrusion, curable resin will be used as a bite registration material. Two pieces of resin will be used as bite registration material, placing them (one piece per each side of the dentition) onto the occlusal surface of the posterior dentition. Then mandible will be guided in the most retruded position, this will be performed with a brief preliminary patient training. When the mandible reaches the desired backward position, the occlusal resin will be cured on both sides. Then the two registration pieces of resin will be fully cured outside of the mouth.
Once fully polymerized they will be checked for integrity, and they will be placed in occlusion to check that final mandibular retrusion is adequate and conforms to planned retrusion. Subsequently, patient maxillo-mandibular relationship in mandibular retrusion will be scanned.
During MMR scan acquisition on the right side, only the left piece of resin will be used to maintain mandibular retrusion. Conversely, during MMR scan acquisition on the left side, only the right piece of resin will be used. At the end of the MMR acquisition process, the software will be able to reorient the maxillary and mandibular scan according to the MMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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)
- •Mild to moderate reverse overjet (-1 to -4)
- •Overbite (1-5)
- •Growing patients
- •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
研究组 & 干预措施
Growing patients with mild skeletal class III
Functional Clear Aligner
干预措施: Functional Clear Aligner (Device)
结局指标
主要结局
Change in skeletal cephalometric measurements
时间窗: Baseline and at the end of active treatment.
Anteroposterior and vertical skeletal changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include SNA (°), SNB (°), ANB (°), Wits appraisal (mm), lower anterior facial height (LAFH, mm), upper anterior facial height (UAFH, mm), total anterior facial height (TAFH, mm), posterior facial height (PFH, mm), Frankfort mandibular plane angle (FMA, °), and Y-axis angle (°).
Change in dentoalveolar cephalometric measurements
时间窗: Baseline and at the end of active treatment.
Dentoalveolar changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper incisor inclination to the SN plane (U1-SN, °), lower incisor inclination to the mandibular plane (IMPA, °), interincisal angle (°), U1-NA (mm and °), and L1-NB (mm and °)
Change in soft tissue cephalometric measurements
时间窗: Baseline and at the end of active treatment.
soft tissue changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper lip to E-line (UL-E, mm), lower lip to E-line (LL-E, mm), and nasolabial angle (°).
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)