跳至主要内容
临床试验/NCT02925468
NCT02925468已完成不适用

Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation

NHS Tayside1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年10月1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
发起方
NHS Tayside
入组人数
38
试验地点
1
主要终点
The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks)

研究概览

简要总结

The correction of a deep overbite is assumed to involve incisor intrusion and the extrusion or eruption of premolars and molars. The latter is also assumed to be the major contributor for growing patients where the vertical facial growth increase accommodates for the additional eruption of posterior teeth with anterior bite plane appliances.

In this study the nature and rate of adaptation of the occlusal changes following insertion of a fixed anterior bite plane for the reduction of a deep overbite in growing patients will be investigated.

详细描述

All subjects who meet the inclusion criteria will be informed of the study and written consent sought for their participation. Subjects will be recruited from the new patient clinics and routine treatment waiting list. A standard initial lateral cephalogram will be taken of all subjects, unless this is already available within the specified age range. Active growth will be determined using the Bacetti CVM method. For the Intervention group - an intra-oral scanner will be used to accurately record the occlusal relationships prior to insertion of the fixed anterior bite plane (T0) and repeated immediately after placement (T1). Each subject will then be re-scanned on a six weekly basis for a period of six months (T2-T5). Conventional clinical photographs and three-dimensional stereophotogrammetry will be used to assess the vertical facial relationships at T0-T5. A further lateral cephalogram will be taken at T5 to assess for skeletal change and assess for evidence of intrusion and eruption as well as determine if there has been an alteration in incisor inclination.

A control group of subjects from the treatment waiting list who meet the inclusion criteria will be used. An intra-oral scanner will record the baseline occlusal relationship (T0) and will be repeated after six months (T5). The control group will also have a standard pre-treatment lateral cephalogram taken, as well as conventional and three-dimensional stereophotogrammetry at baseline (T0) and after six months (T5). This will allow changes resulting from growth to be assessed whilst no active orthodontic treatment has taken place.

The primary outcomes to be assessed will be the nature of the change in occlusal-vertical dimension and the rate of occlusal adaptation in relation to facial growth changes. The intra-oral scans and photographs will be analysed using three-dimensional technology to determine the immediate change and any resultant occlusal adaptation and change in lower face height on a six weekly basis for six months.

All subjects and guardians in the intervention group will be asked to complete a short questionnaire immediately after visits T1 and T5. This will assess their experience of the 3-D scanning and bite planes (if applicable). We will also assess their knowledge of overbite definition, process of overbite reduction and effects of an increased overbite on oral health. The control group will be asked to complete the same questionnaire at T0.

The economic impact of managing the increased overbite as an initial phase of treatment versus single phase comprehensive treatment will be investigated. A cost analysis will be performed to investigate any economic difference in using bite turbos versus a removable appliance to reduce the overbite.

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
None

入排标准

年龄范围
9 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Class II division 2 malocclusion
  • •No history of active orthodontic treatment
  • •Increased overbite (greater than one third lower incisal coverage)

排除标准

  • •Restorations on the palatal surface of the maxillary incisors
  • •Increased overjet where the lower incisor edge occludes distal to the cingulum of the upper incisor
  • •Profound hypodontia (>1 missing tooth per quadrant)
  • •Subjects beyond pubertal growth stage
  • •Suspected or identifiable syndromes
  • •Subjects with cleft lip and palate
  • •Growth anomalies or taking growth accelerating/ inhibiting medication

研究组 & 干预措施

Intervention group

Experimental

A standard initial lateral cephalogram radiograph will be taken of all subjects, unless this is already available within the specified age range. An intra-oral scanner will be used to accurately record the occlusal relationships prior to insertion of the fixed anterior bite plane (bite turbos) (T0) and repeated immediately after placement (T1). Each subject will then be re-scanned on a six weekly basis for a period of six months (T2-T5). Conventional clinical photographs and three-dimensional stereophotogrammetry will be used to assess the vertical facial relationships at T0-T5. A further lateral cephalogram radiograph will be taken at T5.

干预措施: Bite turbo (Device)

Control group

No Intervention

A control group of subjects from the treatment waiting list who meet the inclusion criteria will be used. An intra-oral scanner will record the baseline occlusal relationship (T0) and will be repeated after six months (T5). The control group will also have a standard pre-treatment lateral cephalogram radiograph taken, as well as conventional and three-dimensional stereophotogrammetry at baseline (T0) and after six months (T5). This will allow changes resulting from growth to be assessed whilst no active orthodontic treatment has taken place.

结局指标

主要结局

The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks)

时间窗: Measured 6-weekly for a period of 6 months (T0-T5)

An intra-oral scanner will allow detailed analysis of the occlusal changes following insertion of fixed anterior bite planes. Participants will be re-scanned every 6 weeks for a period of 6 months to determine if and when first molar contact is re-established.

次要结局

  • The nature of occlusal changes following insertion of fixed anterior bite planes(Measured 6-weekly for a period of 6 months (T0-T5))
  • If treatment with bite planes increases participants knowledge of overbite reduction and relation to oral health/ orthodontic treatment (questionnaire)(6 months)
  • Economic impact of using fixed bite planes as an alternative to a removable appliance (measured in pounds sterling)(6 months)
  • The acceptability of fixed anterior bite planes and intra-oral scanning in adolescents (questionnaire)(6 months)

研究者

发起方
NHS Tayside
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Evelyn Dunbar

Principal Investigator

NHS Tayside

研究点 (1)

Loading locations...

相似试验