- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07648485
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.
Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.
Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Systematically healthy male or female subjects aged 16 to 50 years.
- Patients with good oral hygiene.
- Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
- Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
- Presence of functional opposing teeth in stable occlusion
Exclusion Criteria:
- Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
- Current pregnancy or lactation.
- Documented allergy to resin-based composites or adhesive systems.
- Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
- Presence of cracks or fractures involving the tooth structure.
- Active localized or generalized periodontal disease.
- Evidence of parafunctional habits, including bruxism or clenching.
- High caries risk.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Hybrid ceramic group
indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks
|
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks.
the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.
SHOFU HC Primer will be applied to the hybrid-ceramic group.
|
|
Активный компаратор: Composite Resin group
indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks
|
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks.
the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Marginal Adaptation
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
color match
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
marginal discoloration
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
aesthetic anatomic form
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
recurrent caries
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
restoration fracture
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
Post-operative hypersensitivity
Временное ограничение: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Coskun E, Aslan YU, Ozkan YK. Evaluation of two different CAD-CAM inlay-onlays in a split-mouth study: 2-year clinical follow-up. J Esthet Restor Dent. 2020 Mar;32(2):244-250. doi: 10.1111/jerd.12541. Epub 2019 Oct 23.
- Tennert C, Maliakal C, Suarez Machado L, Jaeggi T, Meyer-Lueckel H, Wierichs Richard J. Longevity of posterior direct versus indirect composite restorations: A systematic review and meta-analysis. Dent Mater. 2024 Nov;40(11):e95-e101. doi: 10.1016/j.dental.2024.07.033. Epub 2024 Aug 9.
- Hassan A, Hamdi K, Ali AI, Al-Zordk W, Mahmoud SH. Clinical performance comparison between lithium disilicate and hybrid resin nano-ceramic CAD/CAM onlay restorations: a two-year randomized clinical split-mouth study. Odontology. 2024 Apr;112(2):601-615. doi: 10.1007/s10266-023-00841-w. Epub 2023 Aug 5.
- Fathy H, Hamama HH, El-Wassefy N, Mahmoud SH. Clinical performance of resin-matrix ceramic partial coverage restorations: a systematic review. Clin Oral Investig. 2022 May;26(5):3807-3822. doi: 10.1007/s00784-022-04449-2. Epub 2022 Mar 23.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CairoU-Hybrid Ceramic Inlays
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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