Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL Of Direct 3D-Printed Retainers Versus Thermoformed Retainers: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Post-treatment stability
研究概览
简要总结
Following completion of orthodontic treatment, prolonged retention with either part-time or full-time wear of retainers is crucial in preventing relapse. Clear thermoformed retainers (TFR) are easy to fabricate and popular among orthodontic patients. With the advent of digital orthodontics and the development of biocompatible photopolymerizable resin, it is now possible to fabricate direct 3D-printed retainers.
The aim of this study is to determine and compare the post-treatment stability of dentition, changes in thickness and mechanical properties of the retainers, and oral health-related quality of life (OHRQoL) of patients wearing direct 3D-printed retainers and conventional thermoformed retainers over a retention period of 6 months.
详细描述
Primary Objective:
- To determine and compare the post-treatment stability for direct 3D printed retainers (3DPR) and conventional TFR (TFR) at baseline (T0), 3 months (T1) and 6 months (T2).
Secondary Objectives:
- To determine and compare the thickness and mechanical properties for 3DPR and TFR after 6 months of usage.
- To determine and compare the OHRQoL of patients wearing 3DPR and TFR at T0, T1 and T2.
Sample size calculation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blinded study, where the statistician that analyzes the data is blinded. The subjects are impossible to blind due to subtle differences in the physical appearance of both appliances.
Blinding of the operator will not be possible due to the differences in clinical procedures involved in fabrication of TFR and 3DPR.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fixed appliance treatment in both arches and indicated for VFR in the retention phase as part of their original treatment plan.
- •No intention to relocate within the study period; able to attend the three-monthly review appointments for half a year.
排除标准
- •Single-arch or sectional fixed appliances.
- •Space dentition.
- •Hypodontia requiring tooth replacement on the retainer as a temporary measure.
- •Previous treatment with maxillary expansion.
- •Indicated for fixed retainer or double retention regime (such as VFRs fitted over fixed retainers).
- •Premature debond from the original fixed appliances course.
- •Cleft lip and/or palate; or orthognathic cases.
- •Learning difficulties and inability to read written instructions/ questionnaire in English or Malay
结局指标
主要结局
Post-treatment stability
时间窗: 6 months
The subject's upper and lower dentition will be scanned by using intraoral scanner at T0, T1, and T2. The measurements will be performed digitally using 3Shape orthodontic Analyzer software (3Shape A/S, Copenhagen, Denmark). Measurements: Overjet (mm), Overbite (mm), Intermolar width (mm), and little irregularity index (mm). All the measurements are in millimetres.
次要结局
- Changes in hardness of retainers(6 months)
- Changes in thickness of retainers(6 months)
- Oral Health Impact Profile -14 (OHIP-14)(6 months)
研究者
DR BOO HUI SHAN
Principle Investigator, Doctorate (Orthodontics) Postgraduate Student
University of Malaya