Three-Dimensional Evaluation of Wear and Clinical Survival of Attachments Reproduced With Customized Composites for Clear Aligner Therapy: A Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 3D Surface Wear of Orthodontic Attachments
研究概览
简要总结
This prospective observational clinical study aims to evaluate the three-dimensional surface wear and clinical survival of orthodontic attachments fabricated with customized composite materials used in clear aligner therapy. Attachments play a critical role in the biomechanical efficiency of aligner treatment by facilitating planned tooth movements. However, the mechanical and surface properties of the composites used for attachment fabrication may affect their wear behavior and long-term stability.
In this study, four different composite materials will be tested using a split-mouth design in patients treated with clear aligners. Each quadrant will receive a different composite, including both customized and universal types. All attachments will be fabricated using standardized digital templates and bonded under identical clinical conditions. Surface wear will be evaluated using three-dimensional optical scanning and metrology software at baseline, 1 week, 1 month, 3 months, and 6 months. Lost attachments will be replaced and recorded but excluded from wear analysis.
The results of this study are expected to provide valuable insights into the optimal material selection for clear aligner attachments, improving treatment accuracy and clinical durability.
详细描述
The study is a prospective, observational, split-mouth clinical investigation conducted at the University of Health Sciences, Gülhane Faculty of Dentistry, Department of Orthodontics. It aims to compare the surface wear resistance and clinical performance of attachments fabricated with different composite resins used in clear aligner therapy.
Four composite materials will be evaluated: GC G-ænial A'Chord (control), Spectra ST HV, Spectra ST LV, and GC Aligner Connect. Each patient will receive four different materials applied to separate quadrants following a randomized split-mouth allocation. The study planning and randomization were performed by a single researcher to ensure methodological consistency. All attachments will be fabricated using standardized digital templates based on the virtual treatment plan. The bonding procedure will be carried out by one investigator using Transbond XT adhesive and 37% phosphoric acid etching for 15 seconds.
Intraoral scanning will be performed at baseline, 1 week, 1 month, 3 months, and 6 months. The scanned data will be analyzed using Zeiss Inspect software to quantify volumetric and surface wear. All 3D alignments and superimpositions will be performed by a blinded evaluator to ensure objectivity. Lost or fractured attachments will be recorded and replaced but excluded from quantitative wear analysis.
All participants will be followed for six months. Statistical analysis will include repeated-measures ANOVA and post-hoc testing with a significance level of p < 0.05. Reliability will be evaluated using the intraclass correlation coefficient (ICC).
This study has been approved by the Gülhane Scientific Research Ethics Committee of the University of Health Sciences (Approval No: 2024/015, August 19, 2025). The findings are expected to enhance understanding of how different composite materials influence attachment wear and longevity in clear aligner therapy, thereby improving the accuracy and clinical predictability of treatment outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully erupted permanent dentition.
- •No existing prosthetic restorations.
- •Mild-to-moderate dental crowding or spacing (2-6 mm).
- •Patients who are scheduled to undergo clear aligner therapy at the Department of Orthodontics, Gülhane Faculty of Dentistry, between 01.08.2025 and 01.08.
- •Patients who agree to participate and provide informed consent.
排除标准
- •History of previous fixed orthodontic treatment.
- •Patients with poor predicted compliance or low cooperation.
- •Presence of severe or generalized periodontal disease.
- •High caries incidence or untreated caries.
- •Poor oral hygiene
- •Habitual consumption of hard foods.
- •Congenitally missing permanent teeth.
- •Dental developmental anomalies.
- •Teeth with existing composite resin restorations or ceramic crowns on buccal surfaces (which may interfere with attachment bonding or wear analysis)
研究组 & 干预措施
Group 1: All Participants
All participants receive four different composite materials using a randomized split-mouth design. Each quadrant is assigned one composite for attachment reproduction
干预措施: GC Aligner Connect Composite (Device)
Group 1: All Participants
All participants receive four different composite materials using a randomized split-mouth design. Each quadrant is assigned one composite for attachment reproduction
干预措施: Spectra ST HV (High Viscosity) (Device)
Group 1: All Participants
All participants receive four different composite materials using a randomized split-mouth design. Each quadrant is assigned one composite for attachment reproduction
干预措施: GC G-ænial A'Chord Universal Composite (Device)
Group 1: All Participants
All participants receive four different composite materials using a randomized split-mouth design. Each quadrant is assigned one composite for attachment reproduction
干预措施: Spectra ST LV (Low Viscosity) (Device)
结局指标
主要结局
3D Surface Wear of Orthodontic Attachments
时间窗: Baseline to 6 months
The three-dimensional surface wear of attachments will be evaluated using Zeiss Inspect software (Zeiss GmbH) by comparing baseline (T0) and follow-up scans (T1: 1 week, T2: 1 month, T3: 3 months, T4: 6 months). Wear will be quantified as total surface deviation (sigma) across the entire attachment surface and as point deviations measured at predefined corner and mid-surface points. All 3D alignments and analyses will be performed by an independent, blinded examiner who is unaware of the composite allocation for each quadrant.
次要结局
未报告次要终点