EXD-959 Esthetic Ceramic Self-ligating Orthodontic Brackets and EXD-961 Related Instruments Trial: A Multicenter Case Series Study of the Performance o the EXD-959 Ceramic Bracket System in New and Intercept Orthodontic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 3M
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Performance and functionality of the EXD-959 Bracket System and Related EXD-961 instruments in correcting dental malocclusions.
研究概览
简要总结
The purpose of this study is to assess the performance of the EXD-959 self-ligating ceramic bracket system using EXD 961 instruments in the treatment of orthodontic malocclusion. The information gained in this study and other studies will be used to evaluate the clinical performance of the bracket system during orthodontic treatment and to substantiate marketing claims for the bracket system, open/close instrument and de-bonding instrument.
详细描述
This prospective case-series study will evaluate the performance of the EXD-959 ceramic bracket system at baseline (BL), 4, and 6 months post-baseline, and at the time that each subject has their study brackets debonded (approx. 4 to 24 months). Bond failures and adverse events will be tracked throughout the entire study. A total of 78 study subjects will be enrolled in this study (30 new and 48 intercept cases). The patients will be recruited from a total of 6 participating study sites.
Self-Ligating (SL) Practitioners: The sponsor will recruit 4 orthodontist-investigators who have experience using and currently use self-ligating style orthodontic brackets.
Ligating (L) Practitioners: The sponsor will recruit 2 orthodontist-investigators who do NOT currently use self-ligating style orthodontic brackets in their practices. These will be practitioners who currently use brackets that require that either metal or elastomeric ties are used to secure the archwire into the bracket-slots.
Five new and 8 intercept subjects, who meet the inclusion/exclusion criteria and consent/assent to participate, will be enrolled at each study site (n = 13 per site).
- New patient subjects who are just initiating full orthodontic treatment will have their premolars, canines, and incisors bonded with the EXD-959 brackets, using the related EXD-961 instruments, according to the manufacturer's IFU. Their remaining teeth will be bonded with the brackets of the orthodontist's choice. Three of the 5 new patients recruited may be patients that the orthodontist will choose to initiate treatment with the EXD-959 study brackets being applied to the upper teeth only. Having this option will allow the investigators to recruit subjects with deeper over-bites where their standard of care would be to apply esthetic brackets on the upper teeth and metal brackets on the lower teeth.
- Intercept patient subjects: Eight subjects will be recruited from patients who are currently undergoing orthodontic treatment. Their existing treatment will be intercepted. They will have the brackets currently on their upper and lower premolars, canines, and incisors debonded and replaced with the EXD-959 study brackets, preferably using the related EXD-961 instruments, according the manufacturer's IFU. Three of 8 new intercept patients recruited may have treatment initiated on upper teeth only.
- In order to evaluate rotation correction, torque control, bracket and bracket- door durability, and debonding experiences two types of intercept patients will be targeted:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Able to understand and willing to voluntarily sign the consent/assent form(s);
- •Willing and able to return to the study facility for scheduled visits and recalls;
- •Have permanent dentition including first molars, premolars, canines, and incisors erupted;
- •Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,
- •Have good oral hygiene as determined by the orthodontist/dental hygienist.
- •For intercept patients only:
- •Currently have brackets on their teeth; and,
- •Have begun treatment with rectangular archwires; or, who are in their finishing stage of orthodontic treatment (i.e. they have 3 to 4 months of treatment remaining).
排除标准
- •Currently participating in another clinical study.
- •Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
- •Have mental, emotional, or developmental disabilities.
- •Have a complex/surgical case.
- •Have a deep overbite that would result in their maxillary incisor teeth occluding with the ceramic brackets on the mandibular teeth that cannot be avoided.
- •Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
- •Have dental prostheses/implants that will interfere with projected teeth movement.
- •Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
- •Have a medical or oral condition that, in the investigator's judgement, may compromise the subject's safety or interfere with the conduct and outcome of the study.
结局指标
主要结局
Performance and functionality of the EXD-959 Bracket System and Related EXD-961 instruments in correcting dental malocclusions.
时间窗: The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Validate that the EXD-959 Bracket System and Related EXD-961 instruments meet the user needs based on sponsor solicited feedback from dental professionals using, and patients wearing, these new orthodontic brackets.
次要结局
- Bond strength; assessed using the percent of total brackets that unintentionally debond, as captured on a bond failure tracking form.(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Bracket and door durability assessed using the percent of total brackets that break, or where the door breaks, as captured on a bracket issue tracking form.(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Orthodontists' ability to correct rotated teeth in dental patients as assessed using a questionnaire with a 7-point Likert scale(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Torque control assessed using a questionnaire with a 7-point Likert scale(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Study subjects' assessment of bracket comfort assessed using a a questionnaire with a 7-point Likert scale scale(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Study subjects' assessment of bracket esthetics by using a questionnaire and a 7-point Likert scale.(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)
- Ease of Removal of study brackets when treatment is completed; assessed using a questionnaire and 7-point Likert Scale(The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).)