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NCT07261137 · ClinicalTrials.gov registry record · NA
Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations
A NA study, sponsored by Solventum US.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT07261137: Clinical Trial NA study, sponsored by Solventum US.
NCT07261137 is a NA study that was terminated before completion, run by Solventum US. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07261137, a NA study, was terminated before completion, sponsored by Solventum US.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE Vitrebond™ Pulp Protect Liner/Base
- DEVICE Vitrebond™ Plus (comparator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2026-02-17 |
| Est. Completion | 2026-04-15 |
| Phase | NA |
Why NCT07261137 stopped before completion
NCT07261137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Vitrebond™ Pulp Protect Liner/Base is the first listed.
NCT07261137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07261137 about?
NCT07261137 is a clinical study titled "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. De...
What is the current status of trial NCT07261137?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2026-02-17. Estimated completion is 2026-04-15.
What interventions are being tested in trial NCT07261137?
The interventions under investigation include: Vitrebond™ Pulp Protect Liner/Base (DEVICE), Vitrebond™ Plus (comparator) (DEVICE).
Who is sponsoring clinical trial NCT07261137?
This trial is sponsored by Solventum US, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07261137's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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