Dental Composite and Adhesive System for Tooth Decay

Overseen By Erica Teixeira, DDS, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erica Teixeira

Must not be taking: Desensitizing treatments

Disqualifiers: Periodontal disease, Bruxism, Poor hygiene, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two dental filling systems to determine which is more effective for treating tooth decay. Researchers will place two fillings in each participant, using one system on one tooth and the other system on another. The trial is open to individuals who require similar dental restorations in the front teeth area and have a sensitive tooth that responds to cold or electric testing. As an unphased trial, it offers participants the chance to contribute to dental research and potentially benefit from improved dental treatments.

Will I have to stop taking my current medications?

The trial protocol 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 both treatment options in this dental trial are generally easy for patients to handle. Tokuyama Universal Bond works with various dental materials, having undergone tests for safety and compatibility. This product comes from a company known for reliable dental tools.

ScotchBond Universal, when paired with Filtek Supreme Ultra, also has safety data confirming its suitability for dental procedures. Dentists commonly use and trust this material.

Both treatments have available safety information, including precautions, but no major safety concerns have emerged. Based on current research and their widespread use in dental care, both treatments appear safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for tooth decay because they offer innovative adhesive systems that could enhance dental restoration techniques. The Tokuyama Universal Bond (TUB) system stands out with its single-component, self-etching adhesive that simplifies the application process while ensuring strong bonding. Additionally, the use of Tokuyama's supra-nanofilled dental composite could provide improved durability and aesthetic results compared to traditional options. Meanwhile, the ScotchBond Universal system, paired with Filtek Supreme Ultra™ composite, offers a comparable yet distinct approach with its nanofilled technology, aiming for similar enhancements in durability and aesthetics. Together, these systems have the potential to streamline dental procedures and deliver superior outcomes for patients.

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

This trial will compare two adhesive systems for dental fillings. Research has shown that Tokuyama Universal Bond, which participants in this trial may receive, holds strongly when used with dental fillings. Studies have found it outperforms several other adhesives in preventing cracks, potentially helping fillings stay in place longer and resist wear and tear.

ScotchBond Universal, another treatment option in this trial, has also proven effective. A three-year study demonstrated its reliable bonding performance. It works well in various dental treatments, offering dentists flexibility for different procedures. Both products aim to keep fillings secure and long-lasting, which is crucial for effectively treating tooth decay. ^{4 6 7 8 9}

Who Is on the Research Team?

Erica Teixeira, DDS, MS, PhD

Principal Investigator

University of Iowa College of Dentistry

Are You a Good Fit for This Trial?

This trial is for adults over 18 with tooth decay needing fillings in the front teeth (#4-#13). They must have a recent x-ray and responsive teeth to cold or electric tests. Excluded are those with allergies to dental materials, fewer than 20 teeth, poor oral hygiene, advanced gum disease, cracked teeth, under research team supervision, pregnant women, bruxism sufferers or those unable to attend follow-ups for 3 years.

Inclusion Criteria

Current radiograph available (done at screening as needed)

Sensible tooth -responds to cold or electric pulp testing (done at screening)

You need two identical dental restorations in the front teeth area.

Exclusion Criteria

You have less than 20 teeth.

You have an allergy to materials or ingredients that contain methacrylate.

Individual subordinate to the PI or subordinate to any member of the research team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Placement of dental restorations using System A and System B, including shade selection, cavity preparation, and restoration polishing

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for esthetic outcomes and patient satisfaction at periodic timepoints

60 months

Periodic visits at baseline, 1 year, 3 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adhesive Systems
• Tokuyama Universal Bond

Trial Overview The study compares two types of dental filling composites: System A and System B. Each participant receives one filling from each system in different front teeth. The placement will be done by the same three researchers following a random order determined at the start.

How Is the Trial Designed?

Group I: System A Experimental Treatment 19 Interventions

Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment, clinical assessment

Group II: System B Active Control 19 Interventions

ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment and clinical assessment at periodic timepoints.

Who Is Running the Clinical Trial?

Erica Teixeira

Lead Sponsor

Trials

1

Recruited

40+

Tokuyama Dental Corporation

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

The dual-cure universal adhesive system, Futurabond U, demonstrated reliable clinical performance in non-carious cervical lesions (NCCLs) after 36 months, with retention rates ranging from 87% to 94% across different application strategies.

No postoperative sensitivity or caries recurrence was observed, indicating the safety of the adhesive system, although greater marginal discrepancies were noted in the self-etch groups compared to other strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal Simplified Adhesive applied under different bonding technique's: 36-month Randomized Multicentre Clinical Trial. de Albuquerque, EG., Warol, F., Tardem, C., et al.[2022]

Citations

1. 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 ...

2. multimedia.3m.com multimedia.3m.com/mws/media/1611792O/3m-scotchbond-universal-adhesive-white-paper-us.pdf

3M™ Scotchbond™ Universal Adhesive is worthy of its name. Scotchbond Universal Adhesive gives dentists the freedom to be flexible as they have the option to bond both indirect and direct restorations and to use their ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300571219301964

Clinical and OCT outcomes of a universal adhesive in ... Scotchbond Universal showed an equivalent or improved bonding performance compared to the reference adhesive. Selective enamel etching is recommended. The ...

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

24-Month clinical evaluation of cervical restorations ... also found 85% success rate of root caries restorations after five years using resin composite preceded by self-etch adhesive. A second study by ...

5. multimedia.3m.com multimedia.3m.com/mws/media/1890592O/technical-product-profile-3m-scotchbond-universal-plus-adhesive-int.pdf

technical-product-profile-3m-scotchbond-universal-plus- ... On unetched enamel, bond strength was significantly lower for primary teeth and MIH teeth, although still at a high level of over 25 MPa. This difference may be ...

6. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l00xNxtZP82Unv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet This product is a kit or a multipart product which consists of multiple, independently packaged components. A Safety Data. Sheet (SDS), Article Information ...

7. msdsdigital.com msdsdigital.com/3m-filtek-supreme-ultra-universal-restorative-602860295916-msds

3M Filtek Supreme Ultra Universal Restorative (6028,6029 ... The new SDS required by OSHA are being added daily, to check for a newer version of a safety data sheet, find a SDS from a different manufacture ...

8. henryschein.com henryschein.com/us-en/dental/p/restorative-cosmetic/composites-and-restorative-products/filtek-supreme-ultra-syringe/7770169

3M Filtek Supreme Ultra 6028A1B Universal Composite 3M Filtek Supreme Ultra Universal Restorative Syringe Body Refill is easy to use and offers a wide range of versatility for all your dental composite needs.

9. solventum.com solventum.com/en-us/home/f/b00007967/

3M™ Filtek™ Supreme Ultra Universal Restorative The composite that does it all, Filtek™ Supreme Ultra Universal Restorative ... Safety data sheets. Detailed product composition, safe handling, storage ...