Computer-aided Indirect Bonding Versus Traditional Direct Bonding of Brackets in Orthodontic Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 主要终点
- Time
研究概览
简要总结
Accurate bracket positioning is one of the keys for effective orthodontic treatment. Traditionally, orthodontic brackets are positioned one-by-one on the teeth of the patient, with the so-called direct bonding method.
In the past, the term indirect bonding defined a technique where the brackets were positioned on a plaster model in order to increase placement precision. A transfer tray was then built on the plaster, incorporating all the brackets mounted. Finally, this transfer tray was positioned in the mouth of the patient, so that all the brackets could be bonded to the teeth at once in the pre-determined position. Several studies have investigated this indirect technique based on plaster models.
With computer-aided technology, a new form of digital indirect bonding is now possible. The dentist digitally places the brackets on a virtual 3D model of the teeth. A tray with the brackets' positioning information is then generated with CAD-CAM (computer aided design and manufacturing) technology and the brackets are subsequently indirectly transferred to the teeth. This new approach could possibly save chair time and increase precision. Our profession is today moving towards the virtual reality, and application of such a computer-aided technology method into the clinical work-flow seems definitely promising for our future daily practice.
Since the evidence about this new computer-assisted indirect bracket bonding method is very limited, the purpose of this study is to evaluate precision, chair time, and bracket survival by comparing this digital indirect bonding method to the traditional direct bonding method
Specific objectives
- To assess and compare the accuracy of a conventional direct bonding method with an indirect computer-aided bonding method.
- To evaluate chair time and bracket survival related to both bonding methods.
Hypothesis
Null hypothesis:
I. There is no difference in accuracy of bracket placement between the direct and indirect bonding methods.
II. There is no difference in chair time between the two bonding methods. III. Bracket bond failure is similar for both bonding methods.
Alternative hypothesis:
I. Bracket placement is more precise/accurate with the indirect bonding method compared to the traditional direct bonding method.
II. Indirect bonding reduces chair time.
详细描述
Trial design:
2-arm parallel randomized clinical trial.
Participants, eligibility criteria and settings:
Consecutive patients seeking orthodontic treatment at the Section of Orthodontics, School of Dentistry, Aarhus University, previously selected to be suitable for full fixed appliance with metallic brackets in the Postgraduate clinic, according to treatment needs.
The following inclusion criteria will be applied: minimum 4 permanent teeth (except molars) to be bonded in each of the 4 quadrants (thus extraction or non-extraction cases) and with all teeth fully erupted.
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
- Single (Outcomes Assessor)
盲法说明
During data analysis, anonymization is ensured by assigning a number to each patient, so that the investigator is blinded to the patient's group.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients selected to be suitable for full fixed appliance according to treatment needs and accepting to have metallic brackets.
- •Presence of minimum four permanent teeth (except molars) to be bonded in each of the 4 quadrants (thus extraction or non-extraction cases)
- •All teeth fully erupted.
排除标准
- •Patients with teeth presenting active caries, fluorosis or hypoplasia of enamel, restorations or fractures of the surfaces to be bonded, or abnormalities in crown morphology of the teeth to be bonded.
- •Subjects with major rotations impeding proper bracket positioning.
研究组 & 干预措施
Group 1
Patients had their upper right and lower left quadrants bonded with indirect bonding, and their upper left and lower right quadrants with direct bonding.
干预措施: Direct bonding of Orthodontic brackets (Procedure)
Group 1
Patients had their upper right and lower left quadrants bonded with indirect bonding, and their upper left and lower right quadrants with direct bonding.
干预措施: Indirect bonding of Orthodontic brackets (Procedure)
Group 2
Patients had their upper left and lower right quadrants bonded with indirect bonding, and their upper right and lower left quadrants with direct bonding.
干预措施: Direct bonding of Orthodontic brackets (Procedure)
Group 2
Patients had their upper left and lower right quadrants bonded with indirect bonding, and their upper right and lower left quadrants with direct bonding.
干预措施: Indirect bonding of Orthodontic brackets (Procedure)
结局指标
主要结局
Time
时间窗: On the day the brackets are bonded (bonding date): within 24 hours
Time used for bonding brackets with the CAD/CAM indirect and the traditional direct bonding techniques
次要结局
- Immediate bracket failure rate(On the day the brackets are bonded (bonding date): within 24 hours)
- Cost-minimization analysis(On the day the brackets are bonded (bonding date): within 24 hours)
- Overall bracket failure rate(From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.)
- Bracket position accuracy according to position of the teeth(From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.)
- Bracket position accuracy according to axes of the roots(From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.)
- Bracket position accuracy according to finishing bends(From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.)
- Bracket position accuracy according to number of brackets rebonded(From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.)