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 range7 Years – 89 Years

SexALL

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.
✓. 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

What they're measuring

Pulp Vitality at 1-year

Timeframe: 1 year post-restoration

Trial details

NCT IDNCT07231237

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-15

View on ClinicalTrials.gov More Dental Caries trials