3M Filtek Supreme Composite for Dental Fillings

Overseen By Mariana Bucovsky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Must not be taking: Anti-inflammatory, Analgesic, Mind altering

Disqualifiers: Periodontal disease, Occlusal dysfunctions, others

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

Compensation: Varies

Number of Visits: 5

Duration: Immediate application

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dental filling material called 3M™ Filtek™ Supreme Flowable Composite. The goal is to assess its effectiveness for two dental treatments: class IV restorations and veneers. Participants will undergo follow-up evaluations over two years to monitor the results. The trial seeks individuals with good oral hygiene who need dental work on their front teeth, specifically class IV fillings or veneers. As an unphased trial, participants contribute to advancing dental care by helping evaluate a promising new material.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have a history of chronic use of anti-inflammatory, pain, or mind-altering drugs, you may not be eligible to participate.

What prior data suggests that this composite is safe for dental fillings?

Research has shown that the 3M™ Filtek™ Supreme Flowable Composite, used in dental procedures like veneers and certain tooth repairs, involves some safety considerations. Safety information indicates that this product can cause skin allergies and might affect fertility, potentially leading to skin reactions and impacting the ability to have children. Handling this material carefully can reduce exposure. The composite is typically used with other dental adhesives, common in dental practices. While these findings suggest potential risks, they are not unique to this product and can often be managed with proper precautions. Prospective trial participants should discuss these points with the research team to address any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3M™ Filtek™ Supreme Flowable Composites because they offer a fresh approach to dental restorations like veneers and Class IV restorations. Unlike traditional fillings that rely on bulkier materials, these composites are flowable, allowing for a more precise application and a better fit with the natural tooth structure. This flowable nature can lead to enhanced aesthetics and potentially less invasive procedures. Additionally, the advanced formulation aims to provide durability and resistance to wear, which are crucial for long-lasting dental work.

What evidence suggests that 3M Filtek Supreme Composite is effective for dental fillings?

Research has shown that 3M Filtek Supreme Flowable Composites are effective for dental repairs. In this trial, participants will receive these composites for either veneers or class IV restorations. For class IV restorations, studies have found success rates between 86.2% and 89.7% over five years. These materials quickly and easily match the appearance of natural teeth. For veneers, they have delivered excellent results, with many patients reporting high satisfaction. Additionally, these composites are strong and withstand significant wear and tear over time. ^{4 5 6 7 8}

Who Is on the Research Team?

Kenneth L Allen, DDS

Principal Investigator

NYU College of Dentistry

Are You a Good Fit for This Trial?

This trial is for individuals needing dental fillings or veneers, specifically Class IV restorations and veneers. Participants should be in need of these dental procedures and willing to attend follow-up visits over a two-year period.

Inclusion Criteria

Must be available for the required post-operative follow-up study visits

I have at least 6 front upper teeth.

Must be in good general health

Exclusion Criteria

I don't have any health issues that prevent dental work.

Lack of occlusal stability

I have widespread, untreated tooth decay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3M™ Filtek™ Supreme Flowable Composites for Class IV and veneer restorations

Immediate application

1 visit (in-person)

Follow-up

Participants are monitored for esthetic and functional properties, and survival of treated sites

24 months

4 visits (in-person) at 7 days, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• 3M(TM) Filtek(TM) Supreme Flowable Composites

Trial Overview

The study tests the performance of 3M™ Filtek™ Supreme Flowable Composite in repairing teeth (Class IV) and creating veneers. Patients will be monitored at several intervals up to 24 months using a modified FDI score system.

How Is the Trial Designed?

Group I: Veneers Experimental Treatment 1 Intervention

3MTM FiltekTM Supreme Flowable Composites in veneers

Group II: Class IV Restoration Experimental Treatment 1 Intervention

3MTM FiltekTM Supreme Flowable Composites in class IV restoration

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07128589

3M(TM) Filtek(TM) Supreme Flowable Composites for ...

(2018) reported a success rate of 86.2% for a composite brand and 89.7% for another, in a 5-year evaluation of class IV restorations. A Kaplan ...

2.

multimedia.3m.com

multimedia.3m.com/mws/media/2084833O/3m-filtek-supreme-flowable-restorative-technical-data-sheet.pdf

Technical Data Sheet

In a 10-minute procedure it was possible to esthetically integrate the 3M™ Filtek™. Supreme Flowable Restorative into the patient's natural tooth structure ...

3.

multimedia.3m.com

multimedia.3m.com/mws/media/2280818O/translating-the-science-filtek-supreme-flowable-restorative-now-with-class-i-v-indications.pdf

translating-the-science-filtek-supreme-flowable-restorative- ...

Filtek Supreme Flowable Restorative absorbed the most energy before breaking of the composites tested. Filtek Supreme Flowable Restorative has a slightly lower ...

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/K221695.pdf

June 13, 2022 3M Company ESPE Dental Products Prithul ...

The safety and efficacy of 3M Filtek Supreme Flowable Restorative remain unchanged from the primary predicate, Filtek Supreme Ultra Flowable ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8347401/

Clinical Evaluation of Flowable Composite Materials in ...

The flowable composite materials showed excellent clinical efficacy after 36 months of their clinical usage. There was no difference among the ...

6.

multimedia.3m.com

multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l00xM8mGNYtxMv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1: Identification SECTION 2

Reproductive Toxicity: Category 1B. 2.2. Label elements. Signal word. Page 2. 3M™ Filtek™ Supreme Flowable Restorative.

7.

multimedia.3m.com

multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8lZNUM8mGNYtxMv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1: Identification SECTION 2

This Safety Data Sheet has been prepared in accordance with the Canadian Hazardous Products Regulations. SECTION 1: Identification. 1.1. Product ...

8.

solventum.com

solventum.com/en-us/home/f/b5005163004/

3M™ Filtek™ Supreme Flowable Restorative, Syringe

Class I-V restorations; Base / liner under direct restoration; Repair of small ... Safety data sheets. Detailed product composition, safe handling ...