跳至主要内容
临床试验/CTRI/2025/09/094847
CTRI/2025/09/094847尚未招募3 期

Comparison of clinical effectiveness between 3 Dimensional printed and thermoformed retainers: A randomized clinical trial

Aliya jamal1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Assessment of tooth stability between 3D printed and thermoformed retainer at 0, 1, 3, 6 months of post treatment

研究概览

简要总结

This is a randomized controlled trial using a parallel group study design to compare the effectiveness between 3D printed retainer and thermoformed retainer in post orthodontic patients. Primary objective of my study is to assess and compare the tooth stability between 3D printed and thermoformed retainer over 6 months period. The secondary objective of my study is to compare patient satisfaction and retainer breakage or distortion.•

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patient who have completed fixed orthodontic treatment with all 1st premolar extraction with good alignment and levelling.
  • Patient aged between 14-30 years
  • Patient willing to comply with retainer wear and follow up appointments.
  • No history of allergies or sensitivities to the material used in either retainer type.
  • Patient with no remaining active growth phase.

排除标准

  • Patient with systemic diseases, craniofacial syndromes and condition interfere with tooth movement.
  • Previous orthognathic surgery.
  • Patient with poor oral hygiene or unwillingness to maintain oral hygiene.
  • Patient unwilling or unable to attend follow up visits.
  • Patient with bruxism habit which may damage retainer.

结局指标

主要结局

Assessment of tooth stability between 3D printed and thermoformed retainer at 0, 1, 3, 6 months of post treatment

时间窗: T0 Baseline | T1 After 1 month | T2 After 3 months | T3 After 6 months

次要结局

  • Assessment of patient satisfaction and retainer survival (breakage/distortion) between 3D printed and thermoformed retainer(T0 Baseline)

研究者

发起方
Aliya jamal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aliya jamal

CDER AIIMS NEW DELHI

研究点 (1)

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