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临床试验/NCT04338217
NCT04338217已完成不适用

Evaluation of the Open-bite Bionator Versus the Removable Posterior Bite Plane With a Tongue Crib in the Early Treatment of Skeletal Anterior Open Bite: A Randomized Controlled Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Changes in the Bjork sum

研究概览

简要总结

Open bite is a common dentoalveolar component of the facial pattern of the excessive vertical dimension patients that is also known as the gaping angle face pattern.It is a deformation in the vertical relationship between the upper and the lower dental arches that is characterized by the loss of contact between the opposite dental segments.

详细描述

An open bite develops as a result of the interaction of many etiologic factors, both hereditary and environmental. Prolonged sucking habits and hyper-divergent facial characteristics are significant risk factors for an anterior open bite in the mixed dentition. Abnormal tongue posture (frequently associated with enlarged adenoids or tonsils) and tongue thrust also can be involved in the establishment of alveolar and skeletal discrepancies concurrent with vertical problems Two types of an open bite are recognized in this profession: (1) dentoalveolar open bite: the abnormality formalities aspects limiting in the dental and alveolar region, usually associated with abnormal function habits as the thumb sucking and (2) Skeletal open bite: that's associated with an over high of the lower facial vertical dimension and a large plane angle of the lower jaw. open bites associated with excessive vertical skeletal dimensions are difficult to treat and tend to relapse The investigators must be recognized between the dentoalveolar open bite and the open bite caused by formalities disorders and the position disorders of the upper or the lower jaw or both. Dental an open bite can be corrected by itself if the treatment was beginning early and it's responding Easley to the mechanical treatment methods and the functional treatment approaches that depending on the muscular activity

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
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Anterior open bite (2-10) mm.
  • •Skeletal Class I or II malocclusion.
  • •MP-SN angle ranged between (33-45) degrees.
  • •MM angle ranged between (27-37) degrees.
  • •Age between 7.5-10.5 years.

排除标准

  • •Patients who had an old orthodontic treatment
  • •People with a syndrome or congenital deformity

研究组 & 干预措施

Bionator

Experimental

The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.

干预措施: Bionator (Device)

Removable Appliance with Posterior Bite Planes

Active Comparator

A removable appliance with poster bite planes was used to correct the open bite malocclusion. Patients were asked to wear this appliance full time expect eating times.

干预措施: Removable Appliance with Posterior Bite Planes (Device)

结局指标

主要结局

Changes in the Bjork sum

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

Lateral cephalograms will be taken twice and this measurement is the sum of three different angles: (N-S-Ar + S-Ar-Go +Ar-Go-Me). These angles are well-known to orthodontists.

Changes in the MM angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the maxillary plane and mandibular plane.

Changes in the N-A-Pog angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between three points: N, A, and Pogonion (Pog). N is located on the nasal bone. A is located at the maximum concavity of the anterior upper alveolus between the central incisors. Pog is the located at the most prominent point on the chin contour.

Changes in the UI- LI angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the upper and the lower incisor axes in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the long axis of the upper incisor and the long axis of the lower incisor.

Changes in the NS-GN angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (NS plane) and the the Y-axis plane (i.e. the facial axis plane defined by two points: Sella Point and Gnathion 'Gn' Point).

Change in the SNA angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the position of upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and A.

Changes in the SN-MP angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the mandibular plane (MP plane).

Changes in the posterior facial height (S-Go)

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This will be vertically measured in millimeters from S point to Go point. 'S' point referes to Sella Turcica point. 'Go' point refers to the gonial angle point (located at the corner of the mandibular ramus).

Changes in the SN-OCP angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the SN plane (anterior cranial base plane) and the OCP (occlusal) plane.

Changes in the overbite (Ovb)

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This is a vertical measurement done on the cephalometric tracings in millimeters. It is the vertical overlap between the upper incisors and the lower incisors.

Changes in the overjet (Ovj)

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This is a horizontal measurement done on the cephalometric tracings in millimeters. It is the amount of protrusion of upper incisors in relation to the lower incisors.

Changes in the SN-SPP angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the maxillary plane (SPP plane).

Changes in the 'MentoLab' angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between two planes: the lower lip tangent plane (from 'Labrale inferius' to mentolabial point) and upper anterior chin plane (from mentolabial point to Pogonion point).

Change in the SNB angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This anglrepresents the position of lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and B.

Change in the ANB angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between A, N, and B.

Changes in the 'NasoLab' angle

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the lower nasal tangent (i.e. the plane that touches the lower border of the columella), and the upper lip plane (i.e. the plane that goes through points Subnasale and Labrale Superius).

Changes in the anterior facial height (N-Me)

时间窗: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

This will be vertically measured in millimeters from N point to Me point. 'N' point refers to the Nasion point. 'Me' point refers to the Menton point (located at the lower border of the chin).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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