Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time required to complete bracket bonding procedures, measured in minutes
研究概览
简要总结
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches.
Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.
详细描述
Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.
In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.
The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches
- •Presence of full permanent dentition, including erupted second molars
排除标准
- •Presence of dental anomalies in number (supernumerary or missing teeth) in either arch
- •Orthodontic treatment plans involving tooth extractions in either arch
- •Nickel allergy
- •History of cleft lip and/or palate
- •Craniofacial syndromes
结局指标
主要结局
Time required to complete bracket bonding procedures, measured in minutes
时间窗: During procedure (from the beginning of bracket bonding to completion of bracket placement)
The time required to complete the bracket bonding procedure will be measured in minutes for each participant, from the beginning of the bonding procedure to completion of bracket placement, using the assigned adhesive system.
次要结局
- Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination(1 month after placement of the fixed orthodontic appliance)