Dental Adhesives for Tooth Wear

(SBU+ClassV Trial)

Overseen By John Burgess, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 3M

Disqualifiers: Rampant caries, Chronic periodontitis, Salivary dysfunction, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus and Scotchbond Universal adhesives when used with Filtek restorative. The study will enroll a minimum of 46 Subjects with Class-V non-carious cervical lesion (NCCL) on a minimum of two teeth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is the treatment Scotchbond Universal Adhesive different from other treatments for tooth wear?

Scotchbond Universal Adhesive is unique because it can be used in both self-etch and etch-and-rinse modes, providing flexibility in application. It is designed to bond effectively to both enamel and dentin, which are the hard surfaces of the teeth, and has been shown to maintain bond strength even after aging and cyclic loading. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Scotchbond Universal Adhesive and Scotchbond Universal Plus Adhesive for tooth wear?

Research shows that Scotchbond Universal Adhesive performs well in restoring non-carious cervical lesions, with good retention and marginal adaptation over several years. This suggests it could be effective for tooth wear as well. ^{2 6 7 8 9}

Who Is on the Research Team?

John O Burgess, DDS, MS

Principal Investigator

Louisiana State University HSC Health, School of Dentistry

Are You a Good Fit for This Trial?

This trial is for adults with at least two teeth that have non-carious Class V lesions, which are not dead and haven't had root canal treatment. Participants need good oral hygiene (low plaque levels) and must be healthy enough for dental care as per ASA guidelines. People with allergies to acrylates, salivary gland issues, severe tooth decay or gum disease, or those who can't sit through the dental procedure aren't eligible.

Inclusion Criteria

I can and will attend all required study visits.

Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents

Subject is able to provide their own informed consent

Exclusion Criteria

I have long-term gum disease.

Subject has known sensitivity to the study product components (ie, acrylate)

Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

≤21 days

1 visit (in-person)

Treatment

Restoration procedure using either Scotchbond Universal Plus or Scotchbond Universal adhesives with Filtek restorative

1 day

1 visit (in-person)

Initial Follow-up

Remote visit for subject self-assessment of baseline hypersensitivity

7 days (± 3 days)

1 visit (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

3 visits (in-person) at 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Scotchbond Universal Adhesive
• Scotchbond Universal Plus Adhesive

Trial Overview The study tests two adhesives: Scotchbond Universal Plus and Scotchbond Universal when used with Filtek restorative material on teeth wear lesions. It's a controlled study where each participant receives both treatments in a random order on different teeth.

How Is the Trial Designed?

Group I: SBU+ Treatment Group Experimental Treatment 1 Intervention

Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive .

Group II: SBU Control Group Active Control 1 Intervention

Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive.

Who Is Running the Clinical Trial?

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

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. England pubmed.ncbi.nlm.nih.gov

Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Five-year Clinical Evaluation of Universal Adhesives in Noncarious Cervical Lesions. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of two dentin adhesives in cervical lesions. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Effect of Scotchbond dependent on cavity cleaning, cavity diameter and cavosurface angle. [2019]

6. Iran pubmed.ncbi.nlm.nih.gov

Shear bond strength and scanning electron microscopy characteristics of universal adhesive in primary tooth dentin: An in vitro study. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Bond Capability of Universal Adhesive Systems to Dentin in Self-etch Mode after Short-term Storage and Cyclic Loading. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Aging Methods-An Evaluation of Their Influence on Bond Strength. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Bond Durability of Two-Step HEMA-Free Universal Adhesive. [2022]