Clinical Study Evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pul… (NCT07231237) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Study Evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure
Stopped: The study was terminated early due to a business decision by the sponsor.
United States5 participantsStarted 2026-02-17
Plain-language summary
This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep teeth healthy. The DPC procedure is done by dentists to help preserve tooth health if there is pulp exposure during the tooth restoration or due to trauma. Participants must have at least one permanent tooth with pulp exposure that needs DPC to be eligible for the study.
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 age 7 years or older at time of consent.
. Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
. Subject or Subject's Legally Authorized Representative is able and willing to understand and sign an Informed Consent Form or give Assent, as applicable.
. Subject is able and willing to return in-person for all scheduled study visits.
. Subject is able and willing to follow study restrictions.
. Subject has existing dental radiographic images of the study teeth of current and acceptable diagnostic quality taken within 3 months of tooth restoration.
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.
. Study tooth has healthy periodontal tissues or mildly inflamed tissues not associated with trauma, with probing depths no greater than 4 mm and no gingival recession associated with self-reported sensitivity.
. Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal.
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 (e.g., use of a rubber dam) or the length of time required to complete the restoration(s) on the study tooth/teeth.
. 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 (excluding pain from trauma cases, which may exhibit spontaneous pain due to tooth fracture) within the same quadrant as the study tooth that may interfere with assessment of sensitivity.
. Study tooth diagnosed with cracked tooth syndrome.
. Study tooth mobility \>= grade 2 using the Miller's tooth mobility index.