Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations

This is a clinical study evaluating a new dental product called Solventum™ Vitrebond™ Pulp Protect Liner/Base. This new product is designed to be used as a liner or base between the tooth and the dental filling, as well as for a procedure called direct pulp capping (DPC) if there is exposed pulp. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep your tooth healthy. This study will focus specifically on the liner/base application. In this study, the Solventum study product will be compared to a similar, commercially available product made by Solventum called 3M™ Vitrebond™ Plus Light Cure Glass Ionomer Liner/Base (Vitrebond Plus for short). The study will include participants who are at least 7 years old who have at least one tooth with moderate or advanced caries (tooth decay). The entire duration of the study is anticipated to be 2 years from when the first subject begins the study until the last subject completes the study. The duration of each study subject's participation will be up to 1 year consisting of an initial tooth restoration visit at baseline, a subject self-reported post-operative sensitivity assessment at 1 week reported by phone call, and in-person follow-up assessments at 1 month, 6 months, and 1 year post-restoration to confirm safety and effectiveness. The study will be partially blinded, which means that the participant and the dentist doing the assessments won't know which liner/base product is used on their tooth.

This is a single-site, randomized, controlled, partially blinded, non-inferiority, parallel-group study comparing two liner/base materials: Solventum™ Vitrebond™ Pulp Protect Liner/Base and 3M™ Vitrebond™ Plus. Both products will be used as intended in accordance with their cleared labeling. Restorations on study teeth will be performed in accordance with the relevant manufacturer's Instructions for Use and the clinical investigation plan. Enough Subjects will be enrolled and confirmed eligible to treat 128 teeth with either Vitrebond Pulp Protect or Vitrebond Plus (64 per treatment arm) as the liner/base. A single eligible tooth with moderate or advanced occlusal and/or proximal caries per subject may be included in the study. Randomization will be stratified by caries depth as determined during screening such that there will be a targeted 1:1 ratio of the two treatment arms allocated for each stratum. There will be no minimum size requirement for enrollment by caries depth. Intra-oral photographs will be taken of the prepared tooth on the day of restoration just prior to and just after lining/basing the cavity floor. Standard dental radiographs (x-rays) will be taken at baseline for the screening purposes to determine tooth eligibility. Tooth sensitivity assessments will be self-reported by subjects. All other assessments will be performed by dental examiners who are independent of the dentist who performed the restoration procedure and are blinded to treatment.