Vitrebond™ for Tooth Pulp Exposure

Overseen By Paula Myhre, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Solventum US LLC

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

Disqualifiers: Pregnancy, Breastfeeding, Adverse reactions, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a dental treatment called Vitrebond™ Pulp Protect Liner/Base, designed to protect the inner part of a tooth (the pulp) when exposed. The trial aims to assess the safety and effectiveness of this treatment for individuals with permanent teeth that have pulp exposure due to cavities, injuries, or other accidents. Participants should have at least one permanent tooth requiring a specific dental procedure called direct pulp capping. Individuals with a small pulp exposure in a permanent tooth may be suitable for this study. 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 Vitrebond™ Pulp Protect Liner/Base is safe for direct pulp capping?

Research has shown that Vitrebond™ Pulp Protect Liner/Base has been tested for safety in dental work, but not specifically for covering exposed dental pulp. Some sources advise against its direct use on exposed pulp. While the product may be safe for certain dental applications, more research is needed to confirm its safety for this specific purpose.

Studies have not reported any serious side effects, indicating it is generally well-tolerated in dental procedures. However, since this trial tests the product for a new use, its safety for covering exposed pulp remains under investigation. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Vitrebond™ Pulp Protect Liner/Base is unique because it offers a new approach for direct pulp capping, which is a technique used to protect exposed tooth pulp. Unlike traditional materials like calcium hydroxide or mineral trioxide aggregate, Vitrebond™ uses a light-cured resin-modified glass ionomer that bonds directly to the tooth structure. This bonding capability helps seal the pulp from bacterial infiltration more effectively. Researchers are excited because this could lead to better long-term protection and faster pulp healing.

What evidence suggests that Vitrebond™ might be an effective treatment for tooth pulp exposure?

Research has shown that Vitrebond™, a special dental material, can be effective for direct pulp capping (DPC). It can replace calcium hydroxide, commonly used to protect the soft tissue inside a tooth. In this trial, participants will receive Vitrebond™ Pulp Protect Liner/Base for direct pulp capping. Dentists apply Vitrebond™ to cover and shield the exposed pulp, which can result from cavities or injury. Its effectiveness in maintaining tooth health makes it a promising choice for DPC. Vitrebond™ hardens when exposed to light, simplifying its use for dentists. Overall, it provides a reliable way to protect the inside of a tooth when exposed. ^{6 7 8 9 10}

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 with permanent teeth that have pulp exposure due to deep cavities, trauma, or other causes. Participants must need direct pulp capping (DPC), a procedure to preserve tooth health when the dental pulp is exposed.

Inclusion Criteria

I can understand and sign the consent form, or my legal representative can.

Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria)

Subject is able and willing to follow study restrictions

Exclusion Criteria

Study tooth exhibits bleeding of the exposed pulp that does not stop within 8 minutes

My tooth is diagnosed with cracked tooth syndrome.

My study tooth cannot be fixed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping on permanent teeth with pulp exposure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pulp vitality and other dental health indicators post-restoration

5 years

Scheduled visits at 3 months, 6 months, 1 year, and annually up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Vitrebond™ Pulp Protect Liner/Base

Trial Overview The study tests Solventum™ Vitrebond™ Pulp Protect Liner/Base's safety and effectiveness as a treatment for DPC in teeth with exposed pulps. It aims to see if this liner/base can help maintain the health of affected teeth.

How Is the Trial Designed?

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

Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping

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?lastUpdPost=2020-01-16_

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422968/

The effect of different pulp capping methods on ... Abstract. Background. To evaluate the intra-pulpal temperature during different direct pulp capping methods and light-cured procedures.

3. researchgate.net researchgate.net/publication/328072052_Study_to_evaluate_the_Efficacy_of_Resin-modified_Glass_Ionomer_Cement_Liner_as_a_Direct_Pulp_Capping_Material

Study to evaluate the Efficacy of Resin-modified Glass ... Conclusion: This study shows that Vitrebond™ (3M ESPE) light-cured resin-modified glass ionomer liner can be used as an alternative to calcium ...

4. semanticscholar.org semanticscholar.org/paper/Study-to-evaluate-the-Efficacy-of-Resin-modified-as-Shameem-Muliyar/f432dfbf5546666464ae2992685f3a546fe90c3f

Study to evaluate the Efficacy of Resin-modified Glass ... This study shows that Vitrebond™ (3M ESPE) light-cured resin-modified glass ionomer liner can be used as an alternative to calcium hydroxide as a direct ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3706175/

Comparison of CaOH with MTA for Direct Pulp Capping Based on previous work on pulp capping with CaOH, showing annual failure rates ranging from 5% to 21% (Fitzgerald and Heys, 1991; Matsuo et al., 1996; Clement ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07231237?term=TREATMENt

Clinical Study Evaluating Solventum™ Vitrebond™ Pulp ... The purpose of this clinical study will be to assess the effectiveness and safety of Vitrebond™ Pulp Protect for direct pulp capping on ...

7. nobledentalsupplies.com nobledentalsupplies.com/download/file/1390035a-d028-4c2a-a016-f41b2679b382

Vitrebond™ CONTRAINDICATIONS. Pulp Protection: Vitrebond liner/base is not indicated for direct pulp capping. If a pulp exposure occurs, cover the exposure with a calcium ...

8. dentalkart-media.s3.ap-south-1.amazonaws.com dentalkart-media.s3.ap-south-1.amazonaws.com/PDF/Vitrebond+Tech+Profile.pdf

3m™ vitrebond™ liner/base Vitrebond Liner/Base is not indicated for direct pulp capping. If a pulp exposure occurs, cover the exposure with a calcium hydroxide material. Place the ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230270.pdf

February 6, 2023 3M ESPE Dental Products Prithul Bom Most ... Liner/base, Pulp capping. Liner, Pulp capping agent. Vitrebond Plus liner/base is indicated for lining and basing applications under the.

10. adamdental.com.au adamdental.com.au/Documents/3M%20IFU/Vitrebond%20Plus%20Brochure.pdf?srsltid=AfmBOoonkWfqsxLAcQuYrUEp4lOil7p_pS0PnRNx_VDIfMqiCwnwSofn

Vitrebond Plus Technical Product Profile Pulp Protection: Vitrebond Plus liner/base is not indicated for direct pulp capping. If a pulp exposure has occurred and if the situation warrants a direct pulp ...