Clinical Study Evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure

NCT07231237 | Terminated FDA Device

• 1 other identifier: EM-11-050086
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Pulp Exposure, Dental; Tooth Decay; Dental Decay

Keywords

dental; caries; cavities; pulp exposure; direct pulp capping; Vitrebond Pulp Protect; pulp vitality; dentin bridge; pulp protection

Outcome Measures

Primary Outcomes (1)

• Pulp Vitality at 1-year

  Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint). 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 approximately 30 seconds. 3. Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds. 4. Non-vital pulp: Negative response from the pulp sensibility test.

  1 year post-restoration

Secondary Outcomes (8)

• Pulp Vitality at baseline, 3 months, 6 months, and 2, 3, 4, and 5 years

  Baseline, 3 months, 6 months, and 2, 3, 4, and 5 years post-restoration.

• Reparative dentin formation

  6 months and 1 year, and only if taken at the 2-, 3-, 4-, and 5-year post-restoration

• Apical periodontitis

  6-months and 1-year post-restoration, and at 2-, 3-, 4-, and 5-years post-restoration if periapical radiographs are taken

• Internal root resorption

  6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration

• External root resorption

  6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration

Study Arms (1)

Vitrebond™ Pulp Protect Liner/Base

EXPERIMENTAL

Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping

Device: Vitrebond™ Pulp Protect Liner/Base

Interventions

Vitrebond™ Pulp Protect Liner/Base DEVICE

Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping

Vitrebond™ Pulp Protect Liner/Base

Eligibility Criteria

• Age: 7 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray).
• Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used).
• Study teeth are on opposite right/left sides of the mouth (for Subjects with more than one candidate study tooth).
• Study tooth will be restored no later than 1 month after the date of the first study tooth's restoration (for Subjects with more than one candidate study tooth).
• Subject has one or more permanent teeth with pinpoint pulpal exposure (0.5 mm - 1.0 mm in diameter) needing direct pulp capping, excluding third molars.

You may not qualify if:

• 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.
• Study tooth has previous and current signs and symptoms of pulpal and/or periapical disease (e.g., root resorption or pulpal calcifications) or irreversible pulpitis (excluding pain from trauma cases).
• Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc.)
• Study tooth that is not restorable
• Study tooth that requires a crown preparation.
• Study tooth has an existing restoration or requires a new restoration that interferes with radiographic assessments (e.g., caries on the buccal surface).
• Study tooth exhibits bleeding of the exposed pulp that does not stop within 8 minutes.

Sponsors & Collaborators

• Solventum US LLC: lead

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Miller, S.C, Textbook of periodontia, Blakiston Company, Philidelphia, 1938

  BACKGROUND

MeSH Terms

Conditions

Dental Caries; Dental Pulp Exposure

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Pulp Diseases

Study Officials

• Mabi Singh, DMD, BDS, MS

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-site, single arm clinical study

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: February 17, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)