A Randomized, Controlled, Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 10
- 主要终点
- Prep-and-bonding time
研究概览
简要总结
This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.
详细描述
Traditional Direct bonding bonds each bracket tooth by tooth individually. 3M digital bonding tray is a custom device which can have brackets pre-loaded according to the pre-determined placement by orthodontist prior to patient's arrival to the bonding appointment. This new bonding method allows orthodontist to bond an entire arch of brackets at once, significantly reducing chair time for patients. It is anticipated that patients in digital bonding group have shorter time spent for bonding brackets, less chair time, and fewer adjustment visits than those in direct bonding group.
The treatment arm utilizes a combination of the Digital Bonding Tray and pre adhesive-coated Brackets.
The study control arm will utilize the site's standard of care brackets (pre-adhesive-coated or non-coated) directly and individually applied to teeth. Roughly half of sites will utilize pre-coated brackets and the remaining sites will use uncoated brackets.
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
- None
盲法说明
Due to the nature of the devices, Investigator blinding is not feasible for the study.
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 11 years of age or older.
- •Subject is able and willing to provide their own informed Assent AND Subject or Legal Authorized Representative (LAR) is able and willing to sign the Informed Consent Form
- •Subject is able and willing to be available for all scheduled study visits.
- •The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
- •Subject's current orthodontic treatment plan does not include extractions, orthognathic surgery, post-orthodontic restorative treatment (with the exception of minor spaces for tooth shaping post-orthodontic treatment), or temporary anchorage devices.
- •Subject has all permanent teeth erupted (dentition including second molars or in the opinion of the investigator, the 2nd molars will have completed eruption and alignment during the treatment period).
- •Subject has an Angle Class I or Class II relationships.
- •The Subject has mild to moderate crowding (crowding less than 5 mm in each arch)
- •Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite).
- •The Subject's intra-oral scan must have been taken within 90 days of bracket placement.
- •The Subject is anticipated to complete treatment within 18 to 24 months.
排除标准
- •Subject has a history of adverse reaction to any materials used in this study.
- •Subject is pregnant or breast feeding.
- •Subject has advanced periodontal disease.
- •Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth).
- •Subject has more than 1 tooth excluded from the initial bonding (not including 2nd molars), e.g., no bracket placed on tooth due to position of the tooth at that point in time (tooth turned 90 degrees). Two teeth could be excluded from the initial bonding if an expander is used.
- •Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration).
- •Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis).
- •Subject has erupted 3rd molars in the opinion of the investigator have impact on the treatment duration.
- •Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
研究组 & 干预措施
Treatment Group
Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.
干预措施: Treatment Group Digital Bonding Tray (Device)
Control Group
Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.
干预措施: Control Group Direct Bonding (Device)
结局指标
主要结局
Prep-and-bonding time
时间窗: From the start of teeth preparation to the completion of bonding procedures.
The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth
次要结局
- Number of adjustment visits to complete treatment(Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months))
- Overall chair time(From initial bonding visit to the end of bracket removal visit.)