Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Resto… (NCT07261137) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations
Stopped: The study was terminated early due to a business decision by the sponsor.
United States5 participantsStarted 2026-02-17
Plain-language 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.
Who can participate
Age range
7 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is 7 years of age or older at time of consent.
. Subject or Subject's Legally Authorized Representative is able to understand and willing to sign an Informed Consent Form or give Assent, as applicable.
. Subject is able and willing to attend all scheduled study visits.
. Subject is able and willing to follow study restrictions.
. Subject is in good general health (i.e., meets ASA Level I or ASA Level II classification criteria).
. Subject has at least 1 permanent tooth with moderate or advanced (per ICDAS Guidelines/ADA caries classification system) occlusal and/or proximal caries based upon clinical and/or radiographic evaluation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient self-reported post-operative sensitivity at 1 week
. Subject has existing dental radiographic images of acceptable diagnostic quality taken within 1 month of tooth restoration.
. Study tooth has healthy periodontal tissues or mildly inflamed tissues, with probing depths no greater than 4 mm and no gingival recession associated with self-reported sensitivity.
Exclusion criteria
. Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates.
. Subject is unable, for any reason, to tolerate the study procedures or the length of time required to complete the restoration(s) on the study tooth.
. Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials at any time during the study.
. Subject has a history of chronic use of anti-inflammatory, analgesic (pain), and/or mind-altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter perception of pain.
. Subject is pregnant or breast feeding at the time of screening.
. Subject has any spontaneous or other orofacial pain (including toothache, percussion tenderness, and periapical radiolucency).
. Subject has caries or conditions involving non-study teeth that may interfere with the sensitivity assessments (e.g., advanced caries in a non-study tooth in the same quadrant as the study tooth).
. Subject has Temporal Mandibular Disorder with pain.