Solventum Vitrebond for Tooth Decay

Overseen By Sher-ree Beekman, MBA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Solventum US LLC

Must not be taking: Anti-inflammatory, Analgesic, Mind-altering

Disqualifiers: Pregnancy, Orofacial pain, Trauma, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dental product, Solventum™ Vitrebond™ Pulp Protect Liner/Base, to determine if it protects teeth during fillings better than the existing product, Vitrebond™ Plus. The focus is on teeth with moderate or advanced decay, using the product as a protective layer between the tooth and the filling. Suitable candidates for this trial have at least one permanent tooth with noticeable decay but no existing pain or trauma. Participants will attend regular follow-ups to assess the product's effectiveness and comfort over a year. As an unphased trial, this study offers a unique opportunity to contribute to dental research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have a history of chronic use of anti-inflammatory, pain, or mind-altering drugs, you may not be eligible to participate.

What prior data suggests that this dental product is safe?

Research shows that Solventum™ Vitrebond™ Pulp Protect Liner/Base has undergone safety testing for dental procedures. Although not tested for every possible use, studies have not identified any major safety issues. Users have not experienced significant side effects, indicating good tolerance.

Vitrebond™ Plus Light Cure Glass Ionomer Liner/Base is already available for dental treatments, demonstrating a history of safety in similar situations.

In this trial, both products will serve as a liner or base under dental fillings. Safety data from past research and the current use of Vitrebond Plus suggest these treatments are generally safe for most people. However, minor side effects like temporary sensitivity may occur. Discuss any concerns with a dentist or healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Solventum™ Vitrebond™ Pulp Protect Liner/Base is unique because it offers a novel approach to protecting teeth affected by decay. Unlike standard treatments like dental fillings or sealants that mainly focus on filling cavities, this treatment is designed to act as a protective liner or base, which may enhance the tooth's defense against further decay. Researchers are excited about this treatment because it could provide an additional layer of protection and potentially improve the longevity of dental restorations. By targeting the tooth's pulp directly, this treatment might offer a more comprehensive protective measure compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for tooth decay?

Research shows that Solventum™ Vitrebond™ Pulp Protect Liner/Base, which participants in this trial may receive, may help protect the tooth's pulp. This product creates a barrier between the tooth and the filling, helping to prevent sensitivity and further decay. Early results suggest it effectively protects teeth with moderate to advanced decay by providing a stable base for fillings. It can also be used for direct pulp capping, a procedure that protects the exposed inner part of the tooth, which contains nerves and blood vessels. While specific data on this new product is still being gathered, existing studies support using a liner/base to reduce tooth sensitivity and decay. ^{1 2 3 4 6}

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Initial tooth restoration visit at baseline with intra-oral photographs and x-rays taken

1 day

1 visit (in-person)

Post-operative Sensitivity Assessment

Participants self-report post-operative sensitivity at 1 week via phone call

1 week

1 visit (virtual)

Follow-up

In-person follow-up assessments at 1 month, 6 months, and 1 year post-restoration to confirm safety and effectiveness

1 year

3 visits (in-person)

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07231237?cond=Dentin

Clinical Study Evaluating Solventum™ Vitrebond™ Pulp ...

This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07261137?cond=Dentin+Hypersensitivity

Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/ ...

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 ...

3.

ctv.veeva.com

ctv.veeva.com/study/clinical-study-evaluating-solventum-vitrebond-pulp-protect-liner-base-for-direct-capping-of-pulpal

Clinical Study Evaluating Solventum™ Vitrebond™ Pulp ...

This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping ...

4.

withpower.com

withpower.com/trial/phase-dental-caries-2026-0fe7a

Vitrebond™ for Tooth Pulp Exposure · Info for Participants

This trial tests a dental treatment called Vitrebond™ Pulp Protect Liner/Base, designed to protect the inner part of a tooth (the pulp) when ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12552239/

Efficacy of different cavity liners compared to no cavity lining in ...

This review aimed to evaluate whether the use of a certain cavity lining material (I) in patients with deep caries lesions in mature or immature ...

6.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT07231237

Vitrebond™ Pulp Protect Liner/Base in Dental Caries and Tooth ...

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 ...