Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations

NCT07261137 | Terminated FDA Device

• 1 other identifier: EM-11-050090
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caries, Dental; Tooth Decay; Dental Decay; Tooth Sensitivity

Keywords

dental; caries; liner-base; tooth sensitivity; Vitrebond Pulp Protect; Vitrebond Plus; pulp vitality

Outcome Measures

Primary Outcomes (1)

• Patient self-reported post-operative sensitivity at 1 week

  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.

  1 week

Secondary Outcomes (2)

• Pulp Vitality

  assessed at baseline, 1 month, 6 months, and 1 year after tooth restoration

• Patient self-reported post-operative sensitivity at 1 month

  1 month

Study Arms (2)

Vitrebond™ Pulp Protect Liner/Base

EXPERIMENTAL

Study tooth will be treated with Vitrebond™ Pulp Protect Liner/Base as a liner/base.

Device: Vitrebond™ Pulp Protect Liner/Base

Vitrebond™ Plus

ACTIVE COMPARATOR

Study tooth will be treated with Vitrebond™ Plus (comparator) as a liner/base.

Device: Vitrebond™ Plus (comparator)

Interventions

Vitrebond™ Pulp Protect Liner/Base DEVICE

Vitrebond™ Pulp Protect Liner/Base used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.

Vitrebond™ Pulp Protect Liner/Base

Vitrebond™ Plus (comparator) DEVICE

Vitrebond™ Plus used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.

Vitrebond™ Plus

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 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.
• 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.
• Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray).
• Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal.
• Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used).
• Study tooth involving multiple carious surfaces can be restored with a single, continuous restoration (excluding buccal and lingual surfaces).

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 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.
• Study tooth with current or previous trauma or previous restorations.
• Study tooth diagnosed with cracked tooth syndrome.
• Study tooth with mobility \>= grade 2 using the Miller's tooth mobility index.
• Study tooth has previous and/or current signs or symptoms of pulpal and/or periapical disease (e.g., root resorption or pulpal calcifications) or irreversible pulpitis.
• Tooth surface loss (attrition, erosion, abrasion or abfraction) on study tooth or adjacent teeth that could impact perception of pain.
• Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc).
• Study tooth with pulp exposure under any circumstance (caries exposure, mechanical/traumatic).

Sponsors & Collaborators

• Solventum US LLC: lead

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dental Caries; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mabi Singh, DMD, BDS, MS

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, controlled, partially blinded, clinical study

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 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)