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NCT07261137

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

Sponsor: Solventum US LLC

View on ClinicalTrials.gov

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.

Official title: A Randomized, Controlled Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations

Key Details

Gender

All

Age Range

7 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-01

Completion Date

2027-06

Last Updated

2025-12-03

Healthy Volunteers

Conditions

Caries, Dental Tooth Decay Dental Decay Tooth Sensitivity

Interventions

DEVICE

Vitrebond™ Pulp Protect Liner/Base

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

DEVICE

Vitrebond™ Plus (comparator)

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

Inclusion Criteria: 1. Subject is 7 years of age or older at time of consent. 2. Subject or Subject's Legally Authorized Representative is able to understand and willing to sign an Informed Consent Form or give Assent, as applicable. 3. Subject is able and willing to attend all scheduled study visits. 4. Subject is able and willing to follow study restrictions. 5. Subject is in good general health (i.e., meets ASA Level I or ASA Level II classification criteria). 6. 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. 7. Subject has existing dental radiographic images of acceptable diagnostic quality taken within 1 month of tooth restoration. 8. 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. 9. Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray). 10. Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal. 11. Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used). 12. Study tooth involving multiple carious surfaces can be restored with a single, continuous restoration (excluding buccal and lingual surfaces). Exclusion Criteria: 1. Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates. 2. 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. 3. 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. 4. 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. 5. Subject is pregnant or breast feeding at the time of screening. 6. Subject has any spontaneous or other orofacial pain (including toothache, percussion tenderness, and periapical radiolucency). 7. 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). 8. Subject has Temporal Mandibular Disorder with pain. 9. Study tooth with current or previous trauma or previous restorations. 10. Study tooth diagnosed with cracked tooth syndrome. 11. Study tooth with mobility \>= grade 2 using the Miller's tooth mobility index. 12. 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. 13. Tooth surface loss (attrition, erosion, abrasion or abfraction) on study tooth or adjacent teeth that could impact perception of pain. 14. Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc). 15. Subject is, in the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria. Intra-Operative Exclusion Criteria: 16. Study tooth with pulp exposure under any circumstance (caries exposure, mechanical/traumatic).

Locations (1)

Tufts University

Boston, Massachusetts, United States