Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 3
研究概览
简要总结
The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners.
The main question it aims to answer is:
Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems?
Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction.
Participants will:
- Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning.
- Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days.
- Attend follow-up appointments every 5 weeks.
详细描述
This is a prospective, parallel-arm randomized controlled multi-center clinical trial, to assess and compare the clinical effectiveness of in-office 3D-printed clear aligners with multilayered thermoformed aligners.
The subject population for this study will be male and female subjects aged 16-30 years who have fully erupted permanent dentition and mild dental crowding or spacing.
Methodology:
Patients requiring orthodontic treatment are randomly allocated into two groups.
Experimental Group (DPA): Aligners are fabricated using additive manufacturing (direct 3D printing) with Senertek Clear-A V2 shape-memory resin. This process eliminates the intermediate physical model, potentially reducing cumulative manufacturing errors.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.
- •Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
- •Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.
排除标准
- •Pregnancy, smoking, and systemic conditions affecting bone remodeling.
- •Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene & Vermillion, 1963).
- •Patient with malposed lower second molars (need orthodontic alignment).
- •Allergy to materials used (resins, plastics, solvents).
- •History of trauma, root resorption, and dilacerated roots.
- •Previous extraction or history of previous orthodontic treatment.
研究者
Ali Rahman Issa
Assistant Lecturer, PhD student
University of Baghdad