Dental Adhesives for Cavities

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Solventum US LLC

Disqualifiers: Pregnancy, Advanced periodontal disease, 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 adhesive, Scotchbond Universal Plus Adhesive, to determine its effectiveness compared to the existing Scotchbond Universal Adhesive for filling cavities in back teeth. The trial examines how well the new adhesive bonds to dental fillings compared to the current adhesive. Participants must have at least two back teeth needing fillings on the chewing surface or between teeth. This trial may suit individuals with back teeth requiring fillings who are in good overall health. As an unphased trial, it offers a chance to contribute to dental research and potentially benefit from new adhesive technology.

Do I need to stop my current medications for this dental adhesive trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dental health, so it's unlikely that general medications would be affected, but you should confirm with the study team.

What prior data suggests that these dental adhesives are safe for use in cavity restorations?

Research shows that dentists use the Scotchbond Universal Plus Adhesive to attach fillings to teeth. Although detailed safety information for humans remains limited, the product's safety sheets suggest it is generally safe. For instance, only 12% of its ingredients have unknown effects on skin contact, indicating that most effects are understood.

In contrast, the Scotchbond Universal Adhesive, already widely used, has a proven safety record. This adhesive serves as the standard for comparison with the new Plus version due to its known safety and effectiveness.

Prospective trial participants should consider these points. While the Scotchbond Universal Plus is newer, current data does not indicate any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Scotchbond Universal Plus Adhesive because it offers potential improvements over current dental adhesives used for treating cavities. Unlike traditional adhesives, this new formulation might enhance bonding strength and durability for dental restorations, potentially leading to longer-lasting fillings. Additionally, it simplifies the application process by being versatile enough for different types of cavities, which could make dental procedures more efficient and comfortable for both dentists and patients.

What evidence suggests that this trial's dental adhesives could be effective for cavities?

This trial will compare the effectiveness of Scotchbond™ Universal Plus Adhesive (SBU+) with Scotchbond™ Universal Adhesive (SBU) for dental fillings. Research has shown that SBU+ is effective, with one study demonstrating that it kept fillings perfectly bonded for 24 months. Another study found that SBU+ had a strong bond on both healthy and decayed tooth tissue, indicating its versatility. Additionally, SBU+ showed similar bond strength to the previous version, SBU, when used on decayed teeth. Overall, both adhesives have demonstrated excellent results in keeping fillings secure. Participants in this trial will be randomized to receive either SBU+ or SBU for their dental restorations. ^{6 7 8 9 10}

Who Is on the Research Team?

Jorge Perdigao, DMD, MS, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults aged 18-70 needing two fillings in back teeth (Class I or II) can join this study. Teeth must be healthy, have minimal movement, and not sensitive. Participants need recent x-rays and must be able to sign consent in English without help. Pregnant women, those with severe gum disease, fewer than 20 teeth, or a history of reactions to dental materials cannot participate.

Inclusion Criteria

I am in good health overall.

I can attend all required study visits.

The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.

Exclusion Criteria

I have severe tooth wear from grinding.

The Subject is unable to understand study procedures or provide consent in English.

My tooth is cracked or fractured in a way that might affect its future health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Restoration of two teeth using either Scotchbond Universal Plus Adhesive or Scotchbond Universal Adhesive

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with scheduled follow-up visits

24 months

4 visits (in-person) at 6 months, 12 months, and 24 months post-restoration

What Are the Treatments Tested in This Trial?

Interventions

• Scotchbond Universal Adhesive
• Scotchbond Universal Plus Adhesive

Trial Overview The trial is testing if Scotchbond Universal Plus Adhesive is as good for bonding fillings as the standard Scotchbond Universal Adhesive in adult patients' back teeth. Each participant will get one filling with each adhesive type using Filtek Universal Restorative material.

How Is the Trial Designed?

Group I: Scotchbond Universal Plus Treatment Experimental Treatment 1 Intervention

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).

Group II: Scotchbond Universal Comparator Active Control 1 Intervention

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).

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

3M

Lead Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9737201/

Clinical Outcomes and Quantitative Margin Analysis of a ... The effectiveness of a universal adhesive applied in different application modes for the preparation of Class V composite restorations was evaluated both ...

2. nature.com nature.com/articles/s41598-025-88201-2

24-Month clinical evaluation of cervical restorations ... After 24 months, cervical restorations in Scotchbond™ Universal Adhesive Plus showed 100% alpha score, while in Single Bond Universal group ...

3. researchgate.net researchgate.net/publication/395116673_Evaluation_of_the_Bonding_Performance_of_a_New_Universal_Adhesive_to_Artificially_Created_Caries-Affected_Dentin

Evaluation of the Bonding Performance of a New Universal ... The mean shear bond strength of Scotchbond Universal Plus was 37.32 ± 3.28 MPa on sound dentin and 31.21 ± 2.97 MPa on caries-affected dentin, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40263722/

Bonding Effectiveness of a New Universal Adhesive to ... Regardless of the bonding technique, SBU Plus showed similar bond strength compared to its predecessor when applied to carious dentin of primary molars.

5. researchsquare.com researchsquare.com/article/rs-5165362/v1.pdf?c=1736197814000

Prospective, randomized clinical trial evaluating the ... Clinical relevance– The two dental adhesives used in this clinical trial showed excellent results in posterior restorations at 1 year without ...

6. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l00xNx_Bnx_vMv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet 12% of the mixture consists of ingredients of unknown acute dermal toxicity. Page 5. 3M™ Scotchbond™ Universal Plus Vial (41294, 41295, 41296, ...

7. sdsmanager.com sdsmanager.com/safety-data-sheet/3m-company-3m-scotchbond-universal-plus-l-pop-41298-41299-41304-41308-en/

3M Scotchbond Universal Plus L-Pop (41298, 41299, ... Dental Adhesive ... Effortless setup and maintenance: Simplified Safety Data Sheet Management with compliant Electronic SDS Binder for your employees to access.

8. solventum.com solventum.com/en-us/home/f/b5005223013/

3M™ Scotchbond™ Universal Plus Adhesive Safety data sheets. Detailed product composition, safe handling, storage recommendations and more. Search safety data sheets. opens in a new tab · Customer care ...

9. henryschein.co.nz henryschein.co.nz/documents/msds/LIVE/3M/Scotchbond%20Universal_SDS_EXP_20240410.pdf

Safety Data Sheet Cover-Sheet – This page provides ... 3M™ ESPE™ Scotchbond™ Universal ... Dental Product, Adhesive. For use only by dental professionals. Restrictions on use. For use by dental ...

10. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l_gINx_1OY_v4v70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet IDENTIFICATION: TRANSPORT ... The Dangerous Goods Classification for the complete Kit is provided below. Page 2. 3M™ Scotchbond Universal Plus 100 / 200 / 400 L-POP (41298, ...