Radiographic Analysis of Skeletal and Dentoalveolar Changes Following the Treatment of Mandibular Prognathism and Maxillary Constriction in Growing Patients Using Two Different Treatment Protocols: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in the SNA angle
研究概览
简要总结
This randomized controlled trial intends to test the efficacy of two treatment protocols in the correction of Class III malocclusion with maxillary constriction. We have to options, either to modify the growth using inter-maxillary traction based on an upper fixed appliance that is used in the same time for rapid maxillary expansion or to inhibit mandibular growth by a removable mandibular retractor (RMR) supplied with an expansion screw.
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
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •growing male and female patients aged between 12 and 15 years
- •Angle's class III malocclusion
- •skeletal class III relationship judged clinically and confirmed radiographically (-4 < ANB < + 1)
- •An anterior crossbite involving two or more teeth or an edge-to-edge incisor relationship with or without an anterior shift of the lower jaw upon closure
- •normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
- •maxillary constriction requiring expansion judged clinically and confirmed radiographically
- •permanent dentition
- •no previous orthodontic treatment
排除标准
- •skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA<78° with a normal SNB angle)
- •severe skeletal class III presenting mainly due to mandibular protrusion (ANB < - 4° with no functional shift on closure)
- •contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
- •a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
- •facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
- •MM angle >35° or SN-MP angle > 40°
- •The existence of cleft lip or craniofacial syndromes and/or palate abnormalities and
- •The existence of supernumerary teeth or missing ones except for the third molars.
研究组 & 干预措施
RMR with SME
The removable mandibular retractor (RMR) will inhibit mandibular growth. This appliance will be supplemented with a medline screw that is used for slow maxillary expansion (SME).
干预措施: RMR+SME (Device)
BAIMT with RME
Bone-anchored intermaxillary traction (BAIMT) will be used for Class III correction.
This upper part of the appliance is used for rapid maxillary expansion (RME).
干预措施: BAIMT+RME (Device)
结局指标
主要结局
Change in the SNA angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the MM angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SNB angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
his angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the ANB angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SN-SPP angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the position of the upper jaw (represented by the spinal plane "SPP") in the vertical direction of the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the Witz appraisal
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
Witz appraisal is measured by the anteroposterior distance between the projections of Points A and B onto the functional occlusal plane, measured in mm. It gives an idea about the sagittal relationship between the upper and lower jaws.
Change in the mandibular length
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This distance is measured between the mandibular condyle (Co) and the genial point (Gn).
Change in the ramus height
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This distance is measured between the mandibular condyle (Co) and mandibular gonial angle (Go).
Change in the SN-GoMe angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the position of the lower jaw in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the lower facial height
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This distance is measured between the anterior nasal spine (ANS) and the lower point on the mandibular symphysis (Me).
Change in the A-H variable
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This variable is the horizontal distance between A point (the maxillary bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Change in the B-H variable
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This variable is the horizontal distance between B point (the mandibular bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Change in the Co.Go.Me angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle is created by the intersection between the ramus plane (Co.Go) and the mandibular plane (Go.Me). This is called the gonial angle.
Change in the SN-U1
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees.
Change in the GoMe-L1 angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the relationship of the lower anterior teeth with the mandibular plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SPP-U1 angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This angle represents the relationship of the upper anterior teeth with the SPP plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in ls-E Line distance
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the distance between Ricketts's esthetic line and the upper lip point.
Change in li-E Line distance
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the distance between the lower lip point and esthetic line of Ricketts.
Change in the Gla-Sn-Pog angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the angle between the soft tissue forehead point (Gla) and the subnasal point (Sn) and the most anterior point on the soft tissue chin (Pog).
Change in the naso-labial angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the angle between the upper lip and nasal columella plane.
Change in the labio-mental angle
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the angle between the lower lip and the chin. It is also called the labio-mental fold angle..
Change in the Ag to MZF-j variable
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
Maxillomandibular width right: measured from the Jugal process to the frontofacial plane. This measurement is measured on the frontal cephalogram.
Change in the J-J distance
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
It is the maxillary width measured on the frontal cephalogram.
Change in the molar width at the level of apices (M-MRA)
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This is measured between the apices of the palatal roots of the maxillary first molars (R.RA-L.RA) on the frontal cephalogram.
Change in the molar width at the level of cusps (M-MCT)
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
This is measured between the mesio-palatal cusps tips of the maxillary first molars (R.CT-L.CT) on the frontal cephalogram.
Change in the inferred molar tipping (M-tip)
时间窗: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
The difference between R.RA-L.RA and R.CT-L.CT variables mentioned above and the difference is given in mm.
次要结局
未报告次要终点