An interventional study of Vitrebond™ Pulp Protect Liner/Base and Vitrebond™ Plus (comparator) in Caries, Dental, Tooth Decay and Dental Decay, sponsored by Solventum US LLC. Terminated at 1 site in United States. Open to participants aged 7 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
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Exclusion Criteria:
Subject is, in the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
Intra-Operative Exclusion Criteria:
Study tooth will be treated with Vitrebond™ Pulp Protect Liner/Base as a liner/base.
Device: Vitrebond™ Pulp Protect Liner/Base
Study tooth will be treated with Vitrebond™ Plus (comparator) as a liner/base.
Device: Vitrebond™ Plus (comparator)
Vitrebond™ Pulp Protect Liner/Base used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.
Vitrebond™ Plus used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.
Patient self-reported post-operative sensitivity at 1 week
Tooth sensitivity will be self-reported by subjects prior to tooth restoration to establish baseline, and post-operatively at 1 week post-restoration. Categories for pre/post-operative sensitivity will be graded on the following scale: 1. Absence of pain/sensitivity 2. Mild to moderate pain/sensitivity 3. Severe / Spontaneous pain Spontaneous pain is defined as prolonged intense pain that doesn't respond to pain medication, and/or pain that wakes you up from sleep.
Time frame: 1 week
Pulp Vitality
Pulp vitality assessed by pulp sensibility testing response to cold stimuli (i.e., endo ice). Pulp sensibility testing will be administered at baseline (pre-restoration), 1 month, 6 months, and 1 year post-procedure using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test at the timepoints described is indicative of the pulp vitality of the tooth. A lower score is desired. Categories for pulp vitality will include: 1. Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds. 2. Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to 30 seconds. 3. Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than 30 seconds. 4. Non-vital pulp: Negative response from the pulp sensibility test.
Time frame: assessed at baseline, 1 month, 6 months, and 1 year after tooth restoration
Patient self-reported post-operative sensitivity at 1 month
Tooth sensitivity will be self-reported by subjects prior to tooth restoration to establish baseline, and post-operatively at 1 month post-restoration. Categories for pre/post-operative sensitivity will be graded on the following scale: 1. Absence of pain/sensitivity 2. Mild to moderate pain/sensitivity 3. Severe / Spontaneous pain Spontaneous pain is defined as prolonged intense pain that doesn't respond to pain medication, and/or pain that wakes you up from sleep.
Time frame: 1 month
Plan to share: No
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This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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