Evaluation of the Skeletal and Dentoalveolar Effects of Mini-implant-supported Twin-Block in Treating Growing Patients With Class II Division 1 Malocclusion: 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
- 41
- 试验地点
- 2
- 主要终点
- Change in the SN-MP
研究概览
简要总结
Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.
详细描述
Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. However, these modifications have not been successful in eliminating the dentoalveolar effects. This is because the Twin-Block and other functional appliances are supported by teeth rather than bone. As a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment.
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
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The wrist radiograph (stage 4 S and stage 5 MP3 cap)
- •Skeletal Class II division 1 malocclusion caused by mandibular retrusion
- •ANB (5°- 9°)
- •SNB (72°- 77°)
- •overjet (5 - 8 mm),
- •Minimal crowding in dental arches (≤ 3 mm),
- •lower second molars erupting.
排除标准
- •Previous orthodontic procedures.
- •Systemic diseases.
- •Temporal Mandibular Joint disorders.
- •Poor oral hygiene
结局指标
主要结局
Change in the SN-MP
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient This angle, measured in degrees, represented the relationship between the lower jaw plane and the cranial base in the vertical direction.
Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, was the sum of three angles: the saddle angle (N-S-Ar angle), the articular angle (S-Ar-Go), and the gonial angle (Ar-Go-Me).
Change in the inclination of the upper incisors.
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the upper incisor axis and the anterior cranial base in the anteroposterior direction. It was measured between the upper incisor axis and the SN plane.
Change in the L1-MP angle
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the lower incisor axis and the mandibular base in the anteroposterior direction. It was measured between the lower incisor axis and the Go-Me plane.
Change in the mandibular position relative to the upper jaw
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).
Change in condylar head position
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).
Change in position of the maxillary permanent first molar
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to A Point (in mm).
Change in position of the mandibular permanent first molar
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the mandibular first permanent molar to the Pogonion Point (in mm).
Change in the SN-OP
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the occlusal plane (OP) and the anterior cranial base (the distance between Sella (S) and Nasion (N)) in the vertical direction.
Change in the position of the mandibular base
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).
Change in the overbite
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).
Change in the position of the maxillary base
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).
Change in the composite mandibular length
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).
Change in position of the maxillary incisor
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).
Change in position of the mandibular incisor
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).
Change in the ramus height
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. The distance was measured vertically from the Articular Point (Ar) to the Gonion Point (Go) in millimeters.
Change in the overjet
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the labial surface of the lower central incisor (in mm).
Change in the molar relationship
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to the mesial cusp of the mandibular first permanent molar (in mm).
Change in the corpus length
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the Gonion (Go) Point to the Mention (Me) Point. The distance is measured in mm.
Change in MM angle
时间窗: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. It is calculated for the internal angle formed by the intersection between the maxillary and mandibular planes.
次要结局
未报告次要终点