Evaluation of the efficacy of Direct 3D-printed aligners with that of Thermoformed aligners in resolving lower anterior crowding among adults- A single-blind randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the Little’s Irregularity Index
研究概览
简要总结
The purpose of the study is to compare the efficacy of direct 3D-printed aligners and thermoformed aligners in resolving mild to moderate lower anterior crowding in adult patients. The study aims to evaluate the changes in littles irregularity index along with rate of correction of crowding, treatment duration comparison, number of aligners used, change in mandibular incisor inclination, change in mandibular inter-canine width and amount of interproximal reduction needed
The null hypothesis states that there is no significant difference in the efficacy in the correction of lower anterior crowding with direct 3D-printed aligners and thermoformed aligners.
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
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with fully erupted permanent dentition (excluding third molar) irrespective of gender Healthy, compliant and motivated patients who can visit clinic regularly.
- •Angle’s class I malocclusion with Mild to Moderate lower anterior crowding.
- •Non extraction treatment plan.
- •No history of previous orthodontic treatment.
排除标准
- •Gross gingival/periodontal problems in lower anterior teeth Presence of dental anomalies in the lower anterior teeth Patients with craniofacial syndromes or genetic disorders affecting dentofacial development Prosthetic replacements in lower anterior teeth.
结局指标
主要结局
Change in the Little’s Irregularity Index
时间窗: at baseline (T0), 2 months(T1), 4 months(T2) and post-treatment(T3)
次要结局
- Rate of correction of crowding(4 weeks, 8 weeks, 12 weeks, 16 weeks ,20 weeks, 24 weeks)
- Treatment Duration Comparison(24 weeks)
- Comparison of Number of Aligners Used(24 weeks)
- Change in Mandibular Incisor Inclination (IMPA)(24 weeks)
- Change in mandibular inter-canine width(24 weeks)
- Amount of Interproximal Reduction (IPR)(24 weeks)
研究者
Muhammed Vasil U N
Government dental college, Kozhikode