24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria

一项为期24个月的随机对照临床试验,根据美国公共卫生署(USPHS)和牙科研究所(FDI)的标准,评估了声波活化大块填充树脂复合材料的表面纹理、颜色稳定性和边缘变色情况。

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Abstract

BACKGROUND: To assess the surface texture, color stability, and marginal discoloration of sonic-activated bulk-fill resin composite (BFRC) in comparison to non-sonic-activated BFRC, over 24 months, by two different evaluation criteria. METHODS: 30 adult patients, each presented with at least two carious lesions, either Class I or Class II cavities in their posterior teeth, were selected and subdivided randomly into two identical groups: one group restored with Sonicfill 3 and the other group restored with the X-tra fill, with total of 60 restorations for both groups. Surface texture, color stability, and marginal discoloration were assessed at baseline (1 week), then at 3, 6, 12, and 24-month periods, applying the modified United States Public Health Services (USPHS) criteria and World Dental Federation (FDI) criteria. RESULTS: After the 24-month follow-up evaluation period, there was a non-significant difference in the clinical outcomes between both tested groups, with a non-statistical difference between the results' outcomes evaluated by USPHS or FDI criteria, where all restorations were considered clinically successful by both criteria. CONCLUSIONS: The surface texture, color stability, and marginal discoloration of both tested BFRCs over 24 months were considered clinically successful, either with or without the use of sonic energy. Regarding both criteria, they were reliable, comparable, and suitable for evaluating the clinical performance of RC restorations. TRIAL REGISTRATION: The current study underwent registration at www. CLINICALTRIALS: gov and obtained the unique identification number NCT04926883 for its protocol on 03/06/2021.

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