Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor: a Two-arm Randomized Controlled 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
- Change in the SNA angle
研究概览
简要总结
Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure the selection criteria are accurately matched.
This study compares two groups of patients with mild to moderate skeletal Class III in the late mixed occlusion stage. Experimental group: the patients in this group will be treated with Lower-Clear-Plate Based Intermaxillary Traction Control group: the patients in this group will be treated using the Removable Mandibular Retractor (RMR).
详细描述
There are different methods of correcting Class III deformity in Orthodontics. Lower-clear-plate-based intermaxillary traction has been shown to be an effective method of managing these cases. This treatment modality has not been compared with the well-known appliance (the removable mandibular retractor; RMR). Therefore, the current study compares both groups of growing children with Class III malocclusion. The study design is a randomized controlled trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class III dental malocclusion at the molar relationship, according to Angle's classification
- •Presence of an anterior crossbite on two or more teeth or an edge-to-edge relationship at the anterior teeth
- •Mild to moderate skeletal Class III in the late mixed occlusion stage (9-13 years old) or the beginning of permanent occlusion (not exceeding 13 years old; ANB = +1 to -4 degrees)
- •Normal or horizontal growth pattern (MM ≤ 35; SN.ManP ≤ 40)
- •Normal or labial inclination of the lower incisors (IMPA = 85 to 100 degrees)
- •Patient's willingness to cooperate during the orthodontic treatment period
排除标准
- •Class III skeletal relationship caused solely by the maxillary recession (SNA < 78 and a normal SNB angle)
- •An indication of RME
- •Presence of clear asymmetry (deviation of mandibular midline more than 2 mm from facial midline)
- •Presence of any craniofacial syndromes (such as cleft lip or palate)
- •Systemic diseases; previous facial trauma; and Previous orthodontic treatment.
研究组 & 干预措施
Lower-clear-plate-based intermaxillary traction (LCP-IMT)
Patients in this group will be treated using the LCP-IMT technique.
干预措施: lower-clear-plate-based intermaxillary traction (LCP-IMT) (Device)
Removable mandibular retractor (RMR)
Patients in this group will be treated using the RMR appliance.
干预措施: Removable mandibular retractor (RMR) (Device)
结局指标
主要结局
Change in the SNA angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.
Change in the SNB angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.
Change in the ANB angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.
Change in the S.N.Pog angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction.
Change in the SN-MaxP angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Change in the SN-ManP angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Change in the MaxP.ManP angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Change in the Wits appraisal
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured millimetres horizontally from the projection of points A (AO) and B (BO) along the functional occlusal plane.
Change in the U1.SN angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper central incisor axis and the cranial base in the anteroposterior direction of cephalometric analysis.
Change in the L1-GoMe angle
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower central incisor axis and the mandibular plane in the anteroposterior direction of cephalometric analysis.
Change in the overbite (Ovb)
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Change in the overjet (Ovj)
时间窗: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured millimetres Horizontally from the upper to the lower central incisors.
次要结局
- Change in the Nasolabial angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
- Change in the Soft tissue convexity angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
- Change in the Ls-Esth measurement(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
- Change in the Li-Esth measurement(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
- Change in the Mento-labial angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)