Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial.

Aim and background: The balance between mechanical properties, esthetics, and therapeutic benefits in restorative materials, especially for high-risk patients, is lacking. Effective comparative study designs are required. This randomized clinical trial evaluated the clinical performance of Alkasite bioactive restorative material vs resin-modified glass ionomer (RMGI) in cervical carious lesions according to United States Public Health Service (USPHS) criteria over 1 year.

Materials and methods: Twenty-eight high-risk adult patients with Class V cavities in anterior or premolar teeth were randomly assigned to two groups (n = 14 each). The first group received restorations with an RMGI. In contrast, using a selective etching technique and a universal adhesive, the second group was restored with a bulk-fill alkasite. All materials were applied according to the manufacturer's instructions. The restorations were evaluated at baseline (1 week), after 6 months, and after 12 months using modified USPHS criteria. Data were recorded and statistically analyzed.

Results: Regarding the primary outcome of marginal integrity, no statistically significant difference was found between the alkasite and RMGI restorations at any follow-up interval. However, within the RMGI group, a statistically significant change in marginal integrity was observed across different follow-up periods. All secondary outcomes showed no statistically significant differences in either intragroup or intergroup comparisons at the various follow-up intervals, except for anatomic form, where a statistically significant difference was observed within the RMGI group over different follow-up periods.

Conclusion: Both restorations have shown similar clinical performance over a year, indicating their effectiveness in cervical restorations. Alkasite restoration can successfully replace RMGI for cervical restorations in patients with a high caries index.

Clinical significance: This study addressed the need for restorative materials that balance mechanical strength, esthetics, and therapeutic benefits in high-risk patients. Alkasite restorations are promising alternatives to RMGI. The findings will guide material selection for enhanced functionality, esthetics, and long-term caries prevention.

Clinical trial registration number: NCT04716517. How to cite this article: Al-Salamony H, Akah M, Naguib EA, et al. Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial. J Contemp Dent Pract 2024;25(12):1127-1134.