Randomized Controlled Clinical Trial Of Oral Health-Related Quality Of Life In Patients Wearing Vacuum Formed Thermoplastic Retainers Constructed On Conventional Stone Models And On 3D Reconstructed Orthodontic Study Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Oral Health-Related Quality Of Life
研究概览
简要总结
In dentistry, 3D printing technology is gaining interest. One of the potential application is to construct appliances on 3D reconstructed study models.
The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models by assessing the oral health-related quality of life (OHRQoL) instrument, Little's Irregularity Index (LII) and compliance.
详细描述
Aim:
To compare the impact of 2 types of vacuum formed thermoplastic retainers on patients.
Objectives:
- To compare oral health-related quality of life in patients wearing vacuum formed thermoplastic retainers constructed on a conventional orthodontic study model and reconstructed 3D study model up to 6 months.
- To compare compliance between vacuum formed thermoplastic retainers constructed on a conventional orthodontic study model and reconstructed 3D study model up to 6 months.
- To compare stability in patients wearing vacuum formed thermoplastic retainers constructed on a conventional orthodontic study model and reconstructed 3D study model up to 6 months.
Research Methadology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •fixed appliance treatment following both arches;
- •indicated for vacuum formed thermoplastic retainers as retention phase in treatment plan;
排除标准
- •single-arch or sectional fixed appliance treatment,
- •hypodontia requiring tooth replacement on the retainer as a temporary measure,
- •undergone rapid maxillary expansion,
- •indicated for double retention regime (bonded retainers),
- •early debonding patients.
- •patients intending to relocate within the study period
- •patient with learning difficulties and can't read written instructions/questionnaire in English or Malay
- •patient with cleft lip or palate
- •has undergone surgical treatment
研究组 & 干预措施
Conventional
T1-T2 : VFR constructed on conventional study model T2-T3 : VFR constructed on 3D reconstructed study model
干预措施: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model (Device)
3D
T1-T2 : VFR constructed on 3D reconstructed study model T2-T3 :VFR constructed on conventional study model
干预措施: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model (Device)
结局指标
主要结局
Oral Health-Related Quality Of Life
时间窗: 6 month
次要结局
- Little's Irregularity Index(6 month)