NCT07231237

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

A Multi-site, Single-Arm Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure Due to Trauma, Deep Caries, or Mechanical Etiology Under Dental Restorations

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 7 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-site, single-arm, prospective clinical study evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base treatment for direct pulp capping on permanent teeth. Vitrebond™ Pulp Protect Liner/Base is a new product designed to be placed under dental fillings that can be used as a "Liner/Base" to create a lining between the tooth and the filling to reduce sensitivity, and for direct pulp capping if there is a small amount of dental pulp exposed during the restoration. The purpose of this clinical study will be to assess the effectiveness and safety of Vitrebond™ Pulp Protect for direct pulp capping on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. The primary objective is to evaluate Vitrebond™ Pulp Protect Liner/Base in maintaining pulp vitality (a measure of tooth health) when used for pulp capping, measured at 1-year post-restoration. The secondary objective of this study is to evaluate treated teeth for abnormal clinical signs or symptoms for up to 5 years after treatment to assess long-term safety and effectiveness. The success of Vitrebond™ Pulp Protect for direct pulp capping in this single-arm clinical study will be determined based on an assessment of pulp vitality one year after restoration compared to a pre-specified performance goal derived from literature using calcium hydroxide as the reference comparator.

Conditions

• Dental Caries
• Pulp Exposure, Dental
• Tooth Decay
• Dental Decay

Interventions

Type	Name	Description
DEVICE	Vitrebond™ Pulp Protect Liner/Base	Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2032-02-01
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study