NCT06539676终止不适用
A Prospective, Two-armed, Multicenter Clinical Study to Evaluate Efficacy, Performance, and Safety of Nighttime Aligners (Worn 10-12 Hours Day or Night) Compared to Daytime Aligners (Worn 20-22 Hours Day/Night)
Dentsply Sirona Implants and Consumables24 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 24
- 主要终点
- Peer Assessment Rating (PAR) Index
研究概览
简要总结
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older.
It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator.
The main objectives are:
- Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position)
- Comparison between the two groups concerning the incidence of device or dental related AEs.
- Overall dentist and participant satisfaction with the treatment.
Participants will:
- Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned)
- Attend approximately 5 study during approximately 8-10 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject willing to participate in the clinical study and able to understand the content of the clinical study.
- •Subject must have permanent dentition (i.e. all second molars).
- •Subject must be 12 years of age or older.
- •Subject must be able to provide and sign consent for themselves, without requiring consent to be given by a legally authorized representative. Parental consent is also required for all participants who are not of the legal age to provide consent themselves (based on participant state of residence).
- •The subject requires correction of teeth without planned extrusive movements on either or both arches.
- •The subject has no greater than 5 mm of crowding and/or spacing (based on estimation by Investigator).
- •The subject does not require planned correction of molar tooth positions, posterior bite or molar classic relationship corrections. Subjects with Class II or Class III malocclusions requiring posterior bite / class correction are not eligible.
- •Subjects without prior orthodontic treatment within the past 18 months.
- •Subjects who are periodontally stable.
- •Subjects without a known history of plastic allergies.
- •Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners.
- •Subjects with a treatment plan that does not include the use of elastics.
排除标准
- •Unlikely to be able to comply with clinical study procedures according to Investigator's judgement.
- •Unable or unwilling to return for follow-up visits.
- •Previous enrolment in the present clinical study.
- •Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site)
- •Participation in another clinical study that may interfere with the present clinical study.
- •Subjects who have active carries, where there is no plan to correct them prior to the start of aligner therapy.
- •Other dental or clinical pathologies, which in the judgment of the Investigator, deem the candidates inappropriate for participation in the study (e.g. clinically significant periodontal disease or gingivitis, interproximal decay, etc.).
- •The subject require interproximal reduction or attachments to obtain a corrected malocclusion.
- •In addition to the criteria listed above, this product is contraindicated for use in adult and adolescent subjects presenting with the following dental conditions:
- •Active periodontal disease
- •Severe open bite or severe overjet
- •Tooth malocclusion requiring surgical correction
- •Subject with mixed dentition
- •Subject with a skeletally narrow jaw
- •Dental prosthetics/implants or significant number of missing teeth
- •Known pregnancy, pregnancy tests will be performed as per local requirements.
结局指标
主要结局
Peer Assessment Rating (PAR) Index
时间窗: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
次要结局
- Subject Satisfaction With the Treatment(At the final visit (2-8 months post day 0))
- Dentist (Investigator) Satisfaction With the Treatment(At the final visit (2-8 months post day 0))
- Subject Self-reported Pain/Discomfort(At each follow-up visit (Follow-up visits every 4-6 weeks post Day 0 during a 2-8 months period) and at the final visit (Day 0 + 2-8 months).)
研究者
研究点 (24)
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