Evaluation of Fixed Mandibular Retainer Using 3D Printed Positioning Tray Versus Direct Bonding Technique A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- chairside time
研究概览
简要总结
Although there are many studies in the literature concerning methods of bonding of mandibular retainers whether directly or indirectly, there is a very limited evidence regarding their chair side time and bond failure. Also there are scarce data on fixed mandibular retainers bonded using 3D printed positioning tray.Thus, conducting a well-designed randomized clinical trial evaluating the chair side time and bond failure of 3d printed positioning tray and direct bonding method of fixed mandibular retainer.Null hypothesis is thatThe time needed for direct indirect bonding using 3D digital positioning tray of a mandibular fixed retainer is shorter than the time needed for direct bonding, and there is no difference in failures between the 2 bonding methods
详细描述
Statement of the problem:
- Although there are many studies in the literature concerning methods of bonding of mandibular retainers whether directly or indirectly, there is a very limited evidence regarding their chair side time and bond failure. Also there are scarce data on fixed mandibular retainers bonded using 3D printed positioning tray.
Choice of the comparator:
In the ongoing study, direct bonding of mandibular fixed retainer will be the control group. Thus, conducting a well-designed randomized clinical trial evaluating the chair side time and bond failure of 3d printed positioning tray and direct bonding method of fixed mandibular retainer.
Study rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants Patients can detect the transfer tray so blinding is not possible Operator The main operator is responsible for the bonding so the blinding is not possible Assessor The assessor (different from main operator will carry out the measurement blindly
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with properly finished orthodontic treatment according to ABO standards.
- •the presence of the 4 mandibular incisors and the 2 mandibular canines,
- •No active caries, restorations, fractures, or periodontal disease of these teeth
- •Patient with Good oral hygiene
排除标准
- •• Patients with no need of fixed bonded mandibular retainer
- •No or poor patient's co operation
- •Abnormal morphology of anterior teeth
- •Bad oral hygiene
结局指标
主要结局
chairside time
时间窗: follow up up to 6 month
chairside time for bonding fixed lingual mandibular retainer using stopwatch in measured seconds
次要结局
- bond failure(6 month follow up)
研究者
Raghda Alaa
principal investigator
Cairo University