Split-Mouth Comparison of Invisalign Attachments
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Composite Aligner Attachment.
- Кому может быть актуально
- Состояния в реестре: Wear, Restoration, Volume Assessment, Clear Aligner Appliance. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Accuracy of Invisalign Attachments: A Split-Mouth Comparative Study of Optimized and Conventional Designs
Обзор
This study evaluates how accurately the attachments used in Invisalign treatment (Align Technology Inc., San Jose, CA, USA) match their planned shapes and sizes in the ClinCheck software (ClinCheck®, Align Technology Inc., San Jose, CA, USA). Attachments are small tooth-colored bumps that help clear aligners grip the teeth and move them effectively. The investigators are comparing two types of attachments: optimized and conventional, to determine which is bonded to the tooth more accurately and maintains its shape better over time. Participants beginning Invisalign treatment will have attachments placed as part of their normal care. Digital scans will be taken immediately after placement and during follow-up visits to assess attachment accuracy and wear. The goal is to identify which attachment design provides greater precision and durability to improve the predictability and efficiency of Invisalign treatment planning.
Вмешательства
- Устройство Composite Aligner Attachment
Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points.
Первичные конечные точки
- Attachment Volume Accuracy [Срок оценки: 1 month]
- Attachment Active Surface Area Accuracy [Срок оценки: 1 month]
- Positional Accuracy [Срок оценки: 1 month]
Вторичные конечные точки (4)
- Volume Reduction Over Time [Срок оценки: 6 months]
- Volume Loss (Percentage) [Срок оценки: 6 months]
- Active Surface Area Change Over Time [Срок оценки: 6 months]
- Active Surface Area Change (Percentage) [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Adults aged18 years or older.
- Patients initiating Invisalign treatment with planned composite attachments.
- Ability to provide written informed consent and agree to additional research intra-oral scans.
- Good oral hygiene and absence of active periodontal disease at enrollment.
Критерии исключения
- Extensive dental restorations (composites, crowns, veneers) on study teeth that could interfere with attachment bonding.
- Enamel defects or severe wear on study tooth surfaces affecting bonding accuracy.
- Contraindications to digital intraoral scanning (e.g., severe gag reflex, metallic prostheses preventing accurate imaging).
- Severe tooth malposition that would compromise accurate attachment placement.
- Poor oral hygiene or active periodontal disease at enrollment and/or if the patient develops poor oral hygiene or active periodontal disease during treatment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Maryland School of Dentistry — Baltimore
Публикации
- Muthuswamy Pandian S, Subramanian AK, Vaiid N. Comparison of efficacy and accuracy of tooth movements in optimized and conventional attachments of clear aligners - A systematic review and meta-analysis. J Oral Biol Craniofac Res. 2025 Sep-Oct;15(5):1123-1133. doi: 10.1016/j.jobcr.2025.07.019. Epub 2025 Jul 29. PMID 40778386
- Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186/s40510-023-00506-y. PMID 38369617
- Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007/s00056-023-00471-5. Epub 2023 Jun 14. PMID 37314488
- Bellocchio AM, Portelli M, Ciraolo L, Ciancio E, Militi A, Peditto M, Barbera S, Nucera R. Evaluation of the Clinical Variables Affecting Attachment Reproduction Accuracy during Clear Aligner Therapy. Materials (Basel). 2023 Oct 23;16(20):6811. doi: 10.3390/ma16206811. PMID 37895792
Идентификаторы
NCT: NCT07215598 · HP-00115664