Solventum Vitrebond for Tooth Decay

Overseen By Sher-ree Beekman, MBA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Solventum US LLC

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Mabi Singh, DMD, BDS, MS

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

This trial is for individuals at least 7 years old with moderate to advanced tooth decay. Participants must have one tooth that can be treated with a new dental liner/base product. Those who are allergic to ingredients in the products or have conditions affecting treatment suitability cannot join.

Inclusion Criteria

Subject is able and willing to follow study restrictions

Subject has existing dental radiographic images of acceptable diagnostic quality taken within 1 month of tooth restoration

Study tooth has a positive response to a sensibility test

Exclusion Criteria

Subject has a history of adverse reaction to any materials used in this study, including acrylates

Study tooth with current or previous trauma or previous restorations

Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials

What Are the Treatments Tested in This Trial?

Interventions

• Solventum™ Vitrebond™ Pulp Protect Liner/Base

Trial Overview The study tests Solventum™ Vitrebond™ Pulp Protect Liner/Base against Vitrebond™ Plus, both used under dental fillings or for direct pulp capping. It's a partially blinded study, meaning participants and evaluators don't know which product is applied.

How Is the Trial Designed?

Group I: Vitrebond™ Pulp Protect Liner/Base Experimental Treatment 1 Intervention

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

Group II: Vitrebond™ Plus Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Solventum US LLC

Lead Sponsor

Trials

68

Recruited

10,600+

Bryan Hanson

Solventum US LLC

Chief Executive Officer since 2024

Bachelor's degree in Business Administration from Indiana University

Dr. Ryan Egeland

Solventum US LLC

Chief Medical Officer

MD, trained in Plastic and Reconstructive Surgery