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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two dental adhesives, Scotchbond Universal Adhesive and Scotchbond Universal Plus Adhesive, to determine which is more effective for fixing tooth wear in Class-V non-carious cervical lesions (NCCLs). Participants will receive applications of these adhesives to compare their effectiveness. The trial seeks individuals with at least two teeth exhibiting these specific lesions, which must be at least 1.5 mm deep and have not undergone root canals. As an unphased trial, it provides participants the chance to contribute to dental research and potentially benefit from improved adhesive treatments.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Scotchbond Universal Plus Adhesive is generally well-tolerated in dental procedures. However, it may cause side effects, such as serious eye damage and skin irritation, and there is a risk of an allergic reaction. It might also affect fertility.

In comparison, Scotchbond Universal Adhesive, which is also under study, has been widely used and is generally considered safe for dental work. Both adhesives bond materials to teeth during dental restorations. For concerns about allergies or skin reactions, consult the trial team or your dentist. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Scotchbond Universal Plus (SBU+) Adhesive because it offers a potentially improved solution for restoring teeth with non-carious cervical lesions (NCCLs). Unlike standard dental adhesives, which may not always provide optimal bonding strength or resistance to wear, SBU+ is designed to enhance adhesion and durability in these specific cases. This could lead to longer-lasting restorations and fewer follow-up visits for patients. Additionally, the ease of use and versatility of SBU+ in adhering to different tooth surfaces might make it a more user-friendly option for dental professionals.

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

Research has shown that Scotchbond Universal Plus Adhesive, which participants in this trial may receive, performs exceptionally well for dental repairs. After 24 months, studies found that repairs using this adhesive remained in perfect condition. This new version bonds better with teeth than the previous one. Meanwhile, the regular Scotchbond Universal Adhesive, used in another treatment arm of this trial, also bonds well to teeth and maintains repairs over time. Both adhesives are used with Filtek material, which aids in fixing tooth surfaces. These findings suggest that both adhesives effectively treat worn areas on the neck of the tooth not caused by decay. ^{6 7 8 9 10}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05248204

Study Details | Scotchbond Universal Plus Compared to ... This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth ...

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

Clinical Outcomes and Quantitative Margin Analysis of a ... In a three-year clinical study, composite restorations were placed in all three conditioning modes utilizing Scotchbond™ Universal Adhesive (SBU ...

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1991790223003963

Evaluating the advancements in a recently introduced ... This study investigated the physicomechanical properties and dentin bonding efficacy of a newly upgraded universal adhesive compared to its predecessor.

5. clinicaltrial.be clinicaltrial.be/en/details/175765?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Scotchbond Universal Plus Compared to ... Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative. Any teeth needing treatment that ...

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

Safety Data Sheet This product is a flammable liquid, causes serious eye damage, skin irritation, may cause allergic reaction, and may damage fertility. It is ...

7. 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 ...

8. henryschein.co.nz henryschein.co.nz/restorative-and-cosmetic/bonding/scotchbond-universal-plus-adhesive-unit-dose-400-l-pop

Scotchbond Universal Plus Adhesive Unit Dose 400 L-Pop Scotchbond Universal Plus Adhesive offers a dentin-like radiopacity to reduce the risk of X-ray misdiagnosis and invasive overtreatment. Moreover, it can bond ...

9. darbydental.com darbydental.com/categories/Cosmetic-Dentistry/Bonding-Agents/3M-Scotchbond-Universal-Plus-Adhesive/5251456

3M Scotchbond Universal Plus Adhesive 3M Universal Plus Adhesive is the first radiopaque universal adhesive, minimizing the risk of X-ray misdiagnosis and invasive overtreatment.

10. safcodental.com safcodental.com/product/3m-trade-scotchbond-trade-universal-plus-adhesive?srsltid=AfmBOoqo6SvlcdyOqZIEPxG_HP2MoQSSQmFIBJV-LO9hHy4Evm7UkE56

3M Scotchbond Universal Plus Adhesive Description. The first radiopaque universal adhesive with dentin-like radiopacity minimizes the risk of X-ray misdiagnosis and invasive overtreatment. Features ...