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临床试验/CTRI/2024/06/069055
CTRI/2024/06/069055已完成2 期

Assessing retainer failure occurrence and stability in fixed lingual bonded retainer received post orthodontic patients with and without removable vacuum formed retainer– A pilot randomized controlled trial

KURUNJI KUMARAN N1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Retainer failure occurrence

研究概览

简要总结

Correction of dental malocclusion needs orthodontic intervention. Usually, a comprehensive orthodontic treatment extends up to 24 to 30 months. Retainers are given to patients to preserve the outcome of orthodontic treatment. Among several types of retainers either fixed lingual bonded retainer or removable vacuum formed retainer are commonly used. Fixed retainers are prone for bond failure whereas removable vacuum formed retainers are patient compliance dependent. To overcome this, the concept of hybrid/dual retention, in which the use of removable vacuum formed retainer in addition to fixed lingual bonded retainer has also been practiced. The proponents of this hybrid method claims that it may serve the retention purpose superior than single retainer, in situations wherein a fixed retainer fails and patient not identify it earlier would be reporting to orthodontist only after occurrence of notable relapse. In such situation, if the patient had been provided with a removal vacuum formed retainer to be worn during night time over the fixed retainer, it will act as an additional safety mechanism and the patient will be in safe zone and relapse may not occur until the fixed retainer is repaired or replaced. However, till date there is no scientific evidence to support this. With our acquired knowledge from English literature no previous studies have compared this, hence the goal of the present study is to conduct a pilot RCT to assess retainer failure occurrence, post orthodontic stability periodontal health and patient perception in fixed lingual bonded retainer received post orthodontic patients with and without removable vacuum formed retainer, over a period of 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Both male and female subjects with in the age group of 18 to 30 yrs who had completed a course of fixed appliance therapy (involving both dental arches) with correction of dental malocclusion.
  • Subjects who had maintained good oral hygiene throughout treatment.
  • Subjects who had full and normal complement of teeth in the upper and lower anterior segments before starting orthodontic treatment.
  • Teeth within the anterior segments to be a regular size and shape and not restored or endodontically treated.
  • Subjects who have not underwent periodontal therapy except orthodontic adjunctive minor periodontal procedures before, during or at the end of orthodontic treatment.

排除标准

  • Subjects with any general medical health problems which may influence gingival health such as diabetes mellitus, epilepsy, etc or physical / mental disability.
  • Subjects underwent rapid maxillary expansion or surgically assisted rapid maxillary expansion.
  • Subjects with cleft palate or severe facial deformities.
  • Subjects with severe skeletal malocclusion for which orthognathic surgical correction was carried out.

结局指标

主要结局

Retainer failure occurrence

时间窗: T1(day of retainer delivery) and T2 (end of 6 months).

Post orthodontic stability

时间窗: T1(day of retainer delivery) and T2 (end of 6 months).

次要结局

  • Periodontal health(Patient perception)

研究者

发起方
KURUNJI KUMARAN N
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

KURUNJI KUMARAN N

government dental college cuddalore district

研究点 (1)

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