Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Overbite Change
研究概览
简要总结
Dental anterior open bite is a challenging orthodontic condition with a high risk of relapse in adults. This randomized controlled clinical trial aims to compare the effectiveness and post-treatment stability of in-house clear aligners versus fixed orthodontic appliances in treating adult patients aged 18-30 years with dental anterior open bite (0 to -4 mm).
A total of 46 eligible participants will be randomly allocated into two equal groups (23 treated with clear aligners and 23 with fixed appliances). Treatment outcomes, vertical dentoalveolar changes, and skeletal changes will be evaluated using digital intraoral scans, virtual model superimposition, and lateral cephalometric analysis. Following active treatment, an 8-month retention phase (bonded lingual retainer combined with a vacuum-formed retainer) and an 8-month post-retention follow-up phase will be implemented to comprehensively evaluate treatment stability and relapse tendency over a total observation period of 16 months.
详细描述
Anterior open bite (AOB) in adults presents significant treatment challenges due to the absence of remaining growth and a high relapse tendency. While fixed orthodontic appliances remain the standard approach for vertical control, clear aligner therapy has gained popularity despite limited randomized controlled evidence regarding its long-term predictability and stability.
This study is designed as a single-center, parallel-group, randomized controlled clinical trial conducted at the Faculty of Dentistry, Sana'a University. Enrolled participants meet strict inclusion criteria: adult age (18-30 years), dental anterior open bite (0 to -4 mm), Class I malocclusion with normal molar relationships, non-extraction treatment requirements (crowding/spacing \le 4\text{ mm}), and good oral hygiene.
Participants in the Clear Aligner group receive fully digital in-house aligners fabricated using Zahndent intraoral scans, 3D Maestro setup software, Elegoo Saturn 4 Ultra 16K printing, and PETG thermoforming sheets (0.75-0.8 mm). Aligner mechanics include optimized attachments and medium power intermaxillary elastics (3-4.5 oz) worn 20-22 hours per day. Participants in the Fixed Appliance group are treated using 0.022-inch MBT prescription brackets with a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and vertical elastics.
Primary and secondary outcomes-including overbite increase, cephalometric vertical changes, treatment efficiency, patient compliance, and satisfaction-will be recorded at baseline, post-treatment, after 8 months of retention, and after 8 months of post-retention follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 30 years with fully erupted permanent dentition. Anterior open bite equal to or greater than 2 mm. Angle Class I malocclusion. Good oral hygiene and healthy periodontal status.
排除标准
- •Previous orthodontic treatment. Presence of craniofacial anomalies or cleft lip/palate. Active periodontal disease or severe bone loss. History of temporomandibular joint disorders (TMD). Systemic conditions or medications affecting bone metabolism and tooth movement.
研究组 & 干预措施
Clear Aligner Group
Participants receive in-house manufactured PETG clear aligners (0.75-0.8 mm) designed with 3D Maestro setup software and printed using Elegoo Saturn 4 Ultra 16K. Aligners are changed every 10-14 days, combined with optimized composite attachments and medium power intermaxillary vertical elastics (3-4.5 oz) worn 20-22 hours daily.
干预措施: In-House Clear Aligners (Device)
Fixed Appliance Group
Participants receive conventional fixed orthodontic appliances with 0.022-inch MBT prescription brackets. Treatment utilizes a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and intermaxillary vertical elastics.
干预措施: Fixed Orthodontic Appliances (Device)
结局指标
主要结局
Overbite Change
时间窗: Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.
次要结局
- Cephalometric Skeletal Changes(Baseline and through study completion, an average of 18 months)
- Cephalometric Dental Changes(Baseline and through study completion, an average of 18 months)
研究者
Othman Ahmed Othman
PhD Researcher
Sana'a University