Clinical performance evaluation of nanocomposite resin materials in anterior restorations - Filtek anterior

3M Deutschland GmbH0 个研究点目标入组 190 人开始时间: 2023年4月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Subject is at least 18 years or older at time of consent.
•2. Subject and the subject’s legally designated representative (if applicable) is able to provide their own informed consent.
•3. Subject is willing to return for follow-up examination for at least 2 years
•4. Subject needs at least either one class III or one class IV restoration
•5. Subjects study teeth must have a good prognosis for the next 3 years (e.g., no increased tooth mobility, periodontal probing depth is =5 mm, no signs of pulpitis, no pulp exposure during treatment, study teeth are vital, level of oral hygiene is sufficient with PBI = 30%)
•6. Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

•1. Subjects tooth needs a repair of an already existing class III or class IV restoration
•2. Subject has a known allergies to acrylate-based materials
•3. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study
•4. Subject is experiencing sensitivity and pain of affected tooth
•5. Pulpal exposure of tooth
•6. Subject undergoing any orthodontic treatment
•7. Subject is, in the opinion of the Investigator, unsuitable for enrollment in this study for reasons not specified in the exclusion criteria (e.g., acid erosion or dietary concerns, severe bruxism with loss of vertical height)
•8.Subject cannot withhold the use of bleaching or tooth whitening products besides whitening toothpaste (e.g. carbamide peroxide or hydrogen peroxide gels, strips, trays, or in-office bleaching) during the study period

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