Incidence of White Spot Lesions and Proximal Caries During Orthodontic Treatment With Fixed Pre-adjusted Edgewise Appliances Versus Clear Aligners: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of White Spot Lesions
研究概览
简要总结
This randomized clinical trial evaluates the risk of developing early tooth decay in patients undergoing orthodontic treatment with either traditional fixed braces or clear aligners. Because orthodontic appliances can trap plaque and make tooth cleaning difficult, patients are at a higher risk for developing early decay, such as chalky "white spot lesions" on the visible surfaces of the teeth and hidden decay between the teeth (proximal caries).
In this six-month study, 24 participants are randomly assigned to receive either fixed braces or clear aligners. Researchers will monitor the participants' oral health prior to treatment, at 3 months, and at 6 months. To safely and accurately detect decay, the study uses standard visual examinations for the front of the teeth and a radiation-free optical scanner (Near-Infrared Imaging, or NIRI) to detect hidden cavities between the teeth.
The primary goal of this study is to compare how many new white spot lesions and hidden cavities between teeth develop in each group over the six-month observation period. Additionally, the study tracks how these early lesions behave over time, monitors changes in the patients' daily oral hygiene, and records how often patients in each group require professional dental cleaning procedures. Ultimately, this study aims to help patients and dental professionals make better-informed decisions regarding the specific cavity risks associated with each type of orthodontic appliance.
详细描述
Background and Purpose While orthodontic treatments like traditional braces and clear aligners successfully straighten teeth, they introduce a significant challenge: they make it harder to keep teeth clean. Orthodontic appliances create new areas for dental plaque and bacteria to hide, which can rapidly lead to early tooth decay. This decay typically takes two forms: white spot lesions (WSLs), which are chalky, white marks that form on the visible front surfaces of the teeth, and proximal caries, which is hidden decay that develops in the tight spaces between adjacent teeth.
Historically, it was assumed that clear aligners were a "safer" alternative to braces regarding tooth decay because they can be removed for brushing and flossing. However, clear aligners cover the teeth for 22 hours a day, preventing natural saliva from washing away food and neutralizing acids. Because of this, the actual risk of developing both visible and hidden decay associated with the two treatments required rigorous investigation.
The primary purpose of this 6-month randomized clinical trial was to directly compare the risk, incidence, and behavior of early tooth decay in patients treated with conventional fixed braces versus those treated with clear aligners.
Study Design and Participants
This study was designed as a prospective, randomized clinical trial. A total of 24 eligible adult and adolescent participants who required orthodontic treatment were randomly assigned to one of two groups:
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
- 13 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demographics: Patients aged 13-45 years, possessing fully erupted permanent dentition (excluding third molars).
- •Malocclusion Severity: Skeletal class I according to an ANB angle of 2-4 degrees (Steiner, 1953), moderate lower malalignment of 4-9 mm based on Little's Irregularity Index, and a class I incisor relationship (British Standards Institute, 1983).
- •Treatment Protocol: Comprehensive, dual-arch orthodontic treatment strictly on a non-extraction basis.
- •Handover form from their referring dentist confirming absence of caries requiring restorations and that all indicated restorative therapies have been completed, in addition to no active periodontal disease or pathologic probing depths.
- •No prior history of orthodontic treatment.
- •No full coverage restorations (crowns/veneers) on anterior teeth or premolars.
排除标准
- •Inability to maintain adequate oral hygiene prior to treatment initiation.
- •Dental Anomalies and Missing Teeth: Congenitally missing teeth, presence of dental implants, or impacted teeth (excluding third molars).
- •Structural Enamel Defects: Presence of developmental enamel defects that mimic or obscure demineralization, including enamel hypoplasia, fluorosis, or amelogenesis imperfecta.
- •Fluoride Supplementation: Patients currently utilizing a prescribed, daily supplemental fluoride regimen beyond standard over-the-counter fluoridated toothpaste.
- •Adjunctive Appliances: Treatment plans requiring the use of plaque-retentive adjunct intraoral appliances (e.g., expanders, distalizers).
- •Contraindications to Therapy: Any existing biological contraindications to comprehensive orthodontic tooth movement (e.g., advanced root resorption).
研究组 & 干预措施
Fixed labial braces group
Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.
干预措施: Fixed pre-adjusted edgewise orthodontic appliance (Device)
Clear aligner group
Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.
干预措施: Clear aligner therapy (Device)
结局指标
主要结局
Incidence of White Spot Lesions
时间窗: Up to 6 months (assessed 1 week before treatment at baseline, then 3 months and 6 months into treatment)
The development of new (incident) white spot lesions on the labial surfaces of teeth during orthodontic treatment. Lesions are detected and classified using the visual International Caries Detection and Assessment System (ICDAS).
Incidence of Proximal Caries
时间窗: Baseline (1 week before treatment) and 6 months into treatment.
The development of new caries lesions on the interproximal surfaces of teeth (specifically premolars). Detection is performed non-invasively using Near-Infrared Imaging (NIRI) technology via an intraoral scanner.
次要结局
- Behavior of Early Incident and Pre-existing White Spot Lesions(Assessed at 3 months and 6 months.)
- Change in Oral Hygiene Status(Baseline and 6 months.)
- Frequency of Professional Mechanical Plaque Removal (PMPR)(Up to 6 months.)
研究者
Serene Adnan Badran
Associate Professor in Orthodontics
University of Sharjah