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临床试验/NCT05250765
NCT05250765已完成不适用

Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年9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
入组人数
114
试验地点
1
主要终点
Little Irregularity index

研究概览

简要总结

Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation.

详细描述

The domain of orthodontic retention is controversial. Orthodontic retention is the final step in an orthodontic procedure, and is performed after removal of the orthodontic appliance. Its goal is to prevent the relapse in occlusion or positioning of the teeth. Every patient will need some form of retention to maintain the ideal result. The bonded retainer is frequently used in the lower incisor region. It is capable to prevent relapse of orthodontic treatment but prevents tertiary crowding as well. Advantages of fixed retainers are in general no need for compliance and optimal aesthetics. The retention wire can stay in place for many years. Currently, there is a tendency towards lifelong retention. Disadvantages are more plaque and calculus accumulation, and possibly a poorer periodontal index.

Many types of bonded retainers with different properties could be bonded, each with different effects on periodontal health, potentially a different ability to maintain alignment, and different amounts of failure.

Different types of failure of fixed bonded retainers are possible. When the retainer does not stay in place and is debonded, this is is described as failure. It is also possible the retainer maintains bonded but shows unwanted tooth movement in the bonded teeth. This can also be described as a failure.

Bonding of the retention wire is a technique sensitive process. Correct and passive bonding could prevent debonding of the retainers. To eliminate moisture in the bonding process, it is possible to place a rubberdam before bonding the retainer.

One aim of this study is to compare two types of bonded retainer: the standard coaxial or twisted retainer. The other aim is to compare two bonding protocols with and without rubberdam isolation

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

性别
All
接受健康志愿者
是

入选标准

  • •Fixed orthodontic appliances upper and lower jaw
  • •Patient stays for 2 years in Belgium
  • •Parents consent
  • •Proper oral hygiene

排除标准

  • •Orthognathic surgery
  • •Craniofacial disorders
  • •Cleft lip palate patients
  • •Orthodontic treatment without fixed appliances
  • •Extra retention other than bonded wire in the lower jaw

研究组 & 干预措施

Bonding with rubberdam

Experimental

The retainer is bonded under rubber dam isolation

干预措施: Twistflex retainer (Device)

Bonding with rubberdam

Experimental

The retainer is bonded under rubber dam isolation

干预措施: Orthoflex retainer (Device)

Bonding under relative isolation

Active Comparator

The retainer is bonded under relative isolation (hygrophormic suction, cotton pads)

干预措施: Twistflex retainer (Device)

Bonding under relative isolation

Active Comparator

The retainer is bonded under relative isolation (hygrophormic suction, cotton pads)

干预措施: Orthoflex retainer (Device)

结局指标

主要结局

Little Irregularity index

时间窗: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

Stability of treatment. The index measures the distance, in millimetres, between the contact points of crooked teeth, and then adds them together. Therefore,the Irregularity Index is the sum of all the displaced contacts between the anterior teeth (canine to canine)

次要结局

  • Failure of the retainer (2)(Through study completion (2 years))
  • Periodontal index- BoP(Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3))
  • Failure of the retainer (1)(Through study completion (2 years))
  • Periodontal index- periodontal status(Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3))
  • Periodontal index- plaque(Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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