Closure and Stability of Diastema Associated With Generalized Interdental Spacing Using Clear Aligners Versus Fixed Appliances With Adjunctive Frenectomy: A 2x2 Factorial RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Amount of Diastema Relapse
研究概览
简要总结
This study is a prospective 2x2 factorial randomized clinical trial designed to evaluate and compare the closure efficiency and post-treatment stability of diastema associated with generalized interdental spacing (width >= 3 mm) treated with clear aligners versus fixed orthodontic appliances, with and without adjunctive laser frenectomy. Participants are randomized into four treatment arms to assess the main effects and interaction effects of appliance modality and laser frenectomy. Stability and relapse rates are systematically tracked across active treatment, a 6-month retention period, and post-retention follow-up intervals at 6 and 8 months.
详细描述
Diastema associated with generalized interdental spacing (>= 3 mm) represents a challenging orthodontic condition with a heightened risk of post-treatment relapse. While fixed appliances provide reliable three-dimensional tooth movement control, clear aligners offer improved esthetics and patient comfort. Additionally, the role and timing of adjunctive laser frenectomy in stabilizing space closure remain controversial in generalized spacing cases.
This prospective 2x2 factorial randomized clinical trial is conducted at the Orthodontic Clinics, Faculty of Dentistry, Sana'a University, Yemen. A total of 48 eligible participants are randomly allocated into four equal groups (n=12 per group):
- Group 1: Clear Aligner Therapy with Adjunctive Laser Frenectomy
- Group 2: Clear Aligner Therapy without Frenectomy
- Group 3: Fixed Orthodontic Appliance with Adjunctive Laser Frenectomy
- Group 4: Fixed Orthodontic Appliance without Frenectomy
Treatment Protocols:
- Clear Aligner Group: Digital intraoral scans are obtained using a Zahndent scanner. Virtual treatment planning ensures sequential space closure with root control. Aligners are manufactured by Dentalign Company (Sana'a, Yemen) and worn 20-22 hours daily.
- Fixed Appliance Group: Treated using MBT prescription brackets with a 0.022-inch slot. The archwire sequence includes initial leveling with 0.012 to 0.018 NiTi wires, followed by rectangular stainless steel wires (0.016x0.022, 0.017x0.025, and 0.019x0.025 inches) for space closure and torque control.
- Auxiliary Mechanics: Cervical buttons are bonded in selected teeth across aligner and fixed groups to enhance bodily movement control.
- Adjunctive Laser Frenectomy: Performed using standardized laser technique following partial or complete space closure in designated groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 35 years.
- •Presence of maxillary median diastema associated with generalized interdental spacing (width >= 3 mm).
- •Fully erupted permanent teeth (excluding third molars).
- •Good periodontal health with probing depths <= 3 mm and no bone loss.
- •High motivation and commitment to follow treatment protocols and compliance.
- •Written informed consent provided.
排除标准
- •Previous orthodontic treatment.
- •Severe skeletal malocclusion or craniofacial anomalies.
- •Active periodontal disease, poor oral hygiene, or untreated caries.
- •Missing or impacted permanent teeth in the maxillary arch (excluding third molars).
- •Systemic diseases or long-term medication use affecting bone metabolism or tooth movement (e.g., bisphosphonates, systemic corticosteroids).
- •Pregnant or lactating females.
- •Heavy smokers or individuals with severe parafunctional
研究组 & 干预措施
Clear Aligners with Laser Frenectomy
Participants receive clear aligner therapy for diastema and generalized space closure combined with adjunctive diode laser frenectomy.
干预措施: Clear Aligners (Device)
Clear Aligners with Laser Frenectomy
Participants receive clear aligner therapy for diastema and generalized space closure combined with adjunctive diode laser frenectomy.
干预措施: Laser Frenectomy (Procedure)
Clear Aligners without Laser Frenectomy
Participants receive clear aligner therapy alone for diastema and generalized space closure without frenectomy.
干预措施: Clear Aligners (Device)
Fixed Appliances with Laser Frenectomy
Participants receive conventional fixed orthodontic appliances (MBT 0.022-inch) combined with adjunctive diode laser frenectomy.
干预措施: Fixed Orthodontic Appliance (Device)
Fixed Appliances with Laser Frenectomy
Participants receive conventional fixed orthodontic appliances (MBT 0.022-inch) combined with adjunctive diode laser frenectomy.
干预措施: Laser Frenectomy (Procedure)
Fixed Appliances without Laser Frenectomy
Participants receive conventional fixed orthodontic appliances (MBT 0.022-inch) alone without frenectomy.
干预措施: Fixed Orthodontic Appliance (Device)
结局指标
主要结局
Amount of Diastema Relapse
时间窗: Baseline (0 months), 18 months, 24 months, 30 months, and 32 months
Linear measurement (in millimeters) of maxillary median diastema relapse evaluated on digital 3D models (obtained via intraoral scanner) to measure space reopening post-treatment.
次要结局
- Rate and Efficiency of Diastema Closure(Up to 18 months)
- Root Parallelism and Angulation Changes(Baseline and 18 months)
- Labial Frenum Re-attachment Level(Baseline, 18 months, and 32 months)
研究者
Seham Abdulghani Hamood Alokam
PhD Researcher, Department of Orthodontics
Sana'a University