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

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This study will evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.

Research Team

Jorge Perdigao, DMD, MS, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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