Apply to Trial

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

37 Participants Needed

Dental Composite and Adhesive System for Tooth Decay

Overseen ByErica 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Adhesive Systems, Tokuyama Universal Bond for tooth decay?

Research on similar universal adhesive systems shows they can effectively bond to tooth surfaces, even in challenging conditions, which suggests that Tokuyama Universal Bond might also be effective for treating tooth decay.¹ ² ³ ⁴ ⁵

Is the dental composite and adhesive system safe for humans?

Research on similar adhesive systems, like the Scotchbond Multi-Purpose and Tokuyama's MMA resin cement, has shown that they are generally safe, with studies focusing on their effects on tooth pulp and their ability to seal margins effectively.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the treatment Tokuyama Universal Bond different from other treatments for tooth decay?

Tokuyama Universal Bond is unique because it can bond composite materials to a wide range of dental surfaces, including dentin, enamel, and metal, using both conservative and all-etch techniques. This versatility in bonding makes it stand out compared to other adhesive systems that may not offer such comprehensive surface compatibility.³ ⁸ ¹¹ ¹² ¹³

What is the purpose of this trial?

To compare a newly developed filling composite to a current filling composite system. Two restorations will be placed in each subject, one using system A and one using system B. The first system listed in the randomization pair will be placed on first tooth (#4-#13), and the second system on 2nd tooth (#4-#13). The same three researchers will be responsible for placement of all the restorations.

Research Team

Erica Teixeira, DDS, MS, PhD

Principal Investigator

University of Iowa College of Dentistry

Eligibility Criteria

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

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Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: System AExperimental Treatment19 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 BActive Control19 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erica Teixeira

Lead Sponsor

Trials

Recruited

40+

Tokuyama Dental Corporation

Collaborator

Trials

Recruited

40+

Findings from Research

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]