Dental RestorationNCT07128589
3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
A study testing 3MTM FiltekTM Supreme Flowable Composite in people with Dental Restoration and Dental Veneers, run by New York University at 1 site in United States.
Trial summary
This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Restoration, Dental Veneers
- What is being tested?
- 3MTM FiltekTM Supreme Flowable Composite
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 -75 years old
- must be willing and able to provide informed consent to participate in the study
- must be available for the required post-operative follow-up study visits
- must be in good general health
- must be in good oral health hygiene (FMPS < 20%)
- have at least 6 anterior maxillary teeth
- Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs).
Who cannot join
- Single tooth veneers
- Canines
- Periodontal disease
- Pulpal diseases
- Occlusal dysfunctions (end-to-end bite)
- Lack of occlusal stability
Show all 19Show fewer
- Missing posterior teeth, affecting the occlusal distribution
- Study tooth, adjacent tooth, or opposing tooth with mobility > grade 2 using the Miller's tooth mobility index
- Systemic or local disorders that contra-indicate the dental procedures needed in this study
- Rampant, uncontrolled caries
- Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco
- Evidence of xerostomia
- Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
- Known allergic reaction and/or sensitivity to research materials being used
- Condition or history of chronic use of anti-inflammatory, analgesic (pain), and/or mind altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter the perception of pain
- Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain.
- Taking part in a clinical evaluation of any other dental material
- In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria
- Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU College Of Dentistry
New York, New York, 10010
Leticia Arbex, 212-998-9202, dental.trcresearch@nyu.edu
Kenneth L Allen, DDS
About this study
Official title: Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.
Read the detailed description
Resin composites have been used for anterior restorative solutions as they offer a variety of shades and opacities, reproducing the natural structure correctly. This field in dentistry is increasing as an option for past ceramic restorations, making them accessible and affordable for patients.
The conservative aspect of the adhesive resin composite restorations helped increase the indications for this procedure. Cosmetic contour, also named "no-prep" composite veneers, joined the traditional class III, IV, and V cavities as common indications.
Regular paste composites, used in many layers, are the most adequate option as technique treatment.
Different layers, with specific shades and many levels of opacity/translucency, are combined to reproduce the natural characteristics of teeth. This helps control the shape and dimension of the restoration desired. Nevertheless, the time required for a proper restoration with an esthetic outcome and the need for highly trained skills are the drawbacks for most clinicians.
Flowable consistency composites were developed with some goals to be achieved, such as better adaptation to the cavity, especially in posterior teeth. Additional advantages were a more uncomplicated technique and preventing the resin composite from sticking to the instrument. It has been proved to provide a low elastic modulus layer as a resilient liner before the regular consistency composite restoration. For anterior teeth, flowable composites have been used in clinical evaluations for class V cavities with comparative outcomes concerning regular consistency materials.
Previous evaluations were also conducted for classes I and II in the posterior teeth. Newer, highly filled, flowable composites pushed the traditional techniques for a new injectable technique where a silicone transparent index is made in a previous wax-up field. In this way, a very straight way to reproduce the wax-up is used, guiding the exact shape and texture and overcoming the technical limitations of each professional. The need for clinical data on flowable composites using the injectable technique for anterior veneers and class IV is evident.
Clinical evaluation was done with paste composites used in anterior teeth for composite veneers, which showed a survival rate of 93.4% in a two-year evaluation, similar to 95% of ceramic veneers in the same study. Meijering et al. reported an absolute survival rate of 74% (including absolute and relative failures as endpoints. A retrospective study by Mazzeti et al. described an annual failure rate (AFR) of 9.1% for 5 years and 10% for 10 years. Greisnig et al. (2012) described a survival rate of 87.5% for composite veneers in 3 years and a half, using the USPHS modified method.
A survival rate of 92.86% for class IV restorations was reported for a 4-year evaluation of paste composite resin restorations. Demirci et al. (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 Meier estimate of 9.9 years showed a survival rate of 74.4% for composite resins used in a class IV cavity.
This single-site, non-randomized, clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will follow a Fédération Dentaire Internationale (FDI) modified score used in previous studies. The last version of the modified FDI score was published in 2023, with an update improving the clarity on scoring the composite restorations. This version of the modified FDI score will be applied in our study. Paste composite survival rates reported by literature are the standard of care for the performance of the flowable composite resin used in our study.
- Conditions
- Dental Restoration, Dental Veneers
- Being tested
- 3MTM FiltekTM Supreme Flowable Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3MTM FiltekTM Supreme Flowable CompositeDevice
3M ™ Supreme Flowable Restorative contains BisGMA,TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non/aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
3M (TM) Filtek(TM) Supreme Flowable Restorative is a modification of predicate device 3M(TM) Filtek(TM) XT Flowable Restorative (which was a modification of 3M(TM) Filtek(TM) Flow. 3M Filtek Supreme Flowable Composites are used per indication and its approved labeling in this study.
| Study group | Role | What they receive |
|---|---|---|
| Class IV Restoration | Experimental | 3MTM FiltekTM Supreme Flowable Composites in class IV restoration Receives: Device: 3MTM FiltekTM Supreme Flowable Composite |
| Veneers | Experimental | 3MTM FiltekTM Supreme Flowable Composites in veneers Receives: Device: 3MTM FiltekTM Supreme Flowable Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of treated site over 24 months
Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.
Measured: 24 months
Secondary outcomes (2)
Esthetic Properties evaluation
Esthetic quality scores measured on an ordinal scale of 1-5.
Measured: 24 months
Functional Properties evaluation
Functional Properties scores measured on an ordinal scale of 1-5.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start7 Aug 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Dental RestorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth L Allen, DDS, Principal investigator, NYU College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128589
- Sponsor's protocol ID
- 25-00581
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ricci WA, Fahl N Jr. Nature-mimicking layering with composite resins through a bio-inspired analysis: 25 years of the polychromatic technique. J Esthet Restor Dent. 2023 Jan;35(1):7-18. doi: 10.1111/jerd.13021. Epub 2023 Feb 6.
PubMed 36744374Pontons-Melo JC, Atzeri G, Collares FM, Hirata R. Cosmetic recontouring for achieving anterior esthetics. Int J Esthet Dent. 2019;14(2):134-146.
PubMed 31061994Dietschi D. Free-hand composite resin restorations: a key to anterior aesthetics. Pract Periodontics Aesthet Dent. 1995 Sep;7(7):15-25; quiz 27.
PubMed 9002903Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.
PubMed 21477031Hirata R, Kabbach W, de Andrade OS, Bonfante EA, Giannini M, Coelho PG. Bulk Fill Composites: An Anatomic Sculpting Technique. J Esthet Restor Dent. 2015 Nov-Dec;27(6):335-43. doi: 10.1111/jerd.12159. Epub 2015 Jul 14.
PubMed 26177219Cieplik F, Scholz KJ, Tabenski I, May S, Hiller KA, Schmalz G, Buchalla W, Federlin M. Flowable composites for restoration of non-carious cervical lesions: Results after five years. Dent Mater. 2017 Dec;33(12):e428-e437. doi: 10.1016/j.dental.2017.09.012. Epub 2017 Nov 6.
PubMed 29102158Zhang H, Wang L, Hua L, Guan R, Hou B. Randomized controlled clinical trial of a highly filled flowable composite in non-carious cervical lesions: 3-year results. Clin Oral Investig. 2021 Oct;25(10):5955-5965. doi: 10.1007/s00784-021-03901-z. Epub 2021 Apr 2.
PubMed 33797635Endo Hoshino IA, Fraga Briso AL, Bueno Esteves LM, Dos Santos PH, Meira Borghi Frascino S, Fagundes TC. Randomized prospective clinical trial of class II restorations using flowable bulk-fill resin composites: 4-year follow-up. Clin Oral Investig. 2022 Sep;26(9):5697-5710. doi: 10.1007/s00784-022-04526-6. Epub 2022 May 13.
PubMed 35556174Rocha Gomes Torres C, Rego HM, Perote LC, Santos LF, Kamozaki MB, Gutierrez NC, Di Nicolo R, Borges AB. A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations. J Dent. 2014 Jul;42(7):793-9. doi: 10.1016/j.jdent.2014.04.009. Epub 2014 Apr 25.
PubMed 24769385Coachman C, De Arbeloa L, Mahn G, Sulaiman TA, Mahn E. An Improved Direct Injection Technique With Flowable Composites. A Digital Workflow Case Report. Oper Dent. 2020 May/Jun;45(3):235-242. doi: 10.2341/18-151-T. Epub 2020 Feb 26.
PubMed 32101498Ypei Gia NR, Sampaio CS, Higashi C, Sakamoto A Jr, Hirata R. The injectable resin composite restorative technique: A case report. J Esthet Restor Dent. 2021 Apr;33(3):404-414. doi: 10.1111/jerd.12650. Epub 2020 Sep 11.
PubMed 32918395Imai A, Takamizawa T, Sugimura R, Tsujimoto A, Ishii R, Kawazu M, Saito T, Miyazaki M. Interrelation among the handling, mechanical, and wear properties of the newly developed flowable resin composites. J Mech Behav Biomed Mater. 2019 Jan;89:72-80. doi: 10.1016/j.jmbbm.2018.09.019. Epub 2018 Sep 17.
PubMed 30265868Elkaffas AA, Alshehri A, Alqahtani AR, Abuelqomsan MA, Deeban YAM, Albaijan RS, Alanazi KK, Almudahi AF. Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: Two-Year Follow-Up. Materials (Basel). 2024 Jul 16;17(14):3514. doi: 10.3390/ma17143514.
PubMed 39063806Meijering AC, Creugers NH, Roeters FJ, Mulder J. Survival of three types of veneer restorations in a clinical trial: a 2.5-year interim evaluation. J Dent. 1998 Sep;26(7):563-8. doi: 10.1016/s0300-5712(97)00032-8.
PubMed 9754744Mazzetti T, Collares K, Rodolfo B, da Rosa Rodolpho PA, van de Sande FH, Cenci MS. 10-year practice-based evaluation of ceramic and direct composite veneers. Dent Mater. 2022 May;38(5):898-906. doi: 10.1016/j.dental.2022.03.007. Epub 2022 Apr 1.
PubMed 35379471
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
- ClinicalTrials.gov ID
- NCT07128589
- Acronym / sponsor ID
- 25-00581
- Conditions
- Dental Restoration, Dental Veneers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.
Detailed description
Resin composites have been used for anterior restorative solutions as they offer a variety of shades and opacities, reproducing the natural structure correctly. This field in dentistry is increasing as an option for past ceramic restorations, making them accessible and affordable for patients.
The conservative aspect of the adhesive resin composite restorations helped increase the indications for this procedure. Cosmetic contour, also named "no-prep" composite veneers, joined the traditional class III, IV, and V cavities as common indications.
Regular paste composites, used in many layers, are the most adequate option as technique treatment.
Different layers, with specific shades and many levels of opacity/translucency, are combined to reproduce the natural characteristics of teeth. This helps control the shape and dimension of the restoration desired. Nevertheless, the time required for a proper restoration with an esthetic outcome and the need for highly trained skills are the drawbacks for most clinicians.
Flowable consistency composites were developed with some goals to be achieved, such as better adaptation to the cavity, especially in posterior teeth. Additional advantages were a more uncomplicated technique and preventing the resin composite from sticking to the instrument. It has been proved to provide a low elastic modulus layer as a resilient liner before the regular consistency composite restoration. For anterior teeth, flowable composites have been used in clinical evaluations for class V cavities with comparative outcomes concerning regular consistency materials.
Previous evaluations were also conducted for classes I and II in the posterior teeth. Newer, highly filled, flowable composites pushed the traditional techniques for a new injectable technique where a silicone transparent index is made in a previous wax-up field. In this way, a very straight way to reproduce the wax-up is used, guiding the exact shape and texture and overcoming the technical limitations of each professional. The need for clinical data on flowable composites using the injectable technique for anterior veneers and class IV is evident.
Clinical evaluation was done with paste composites used in anterior teeth for composite veneers, which showed a survival rate of 93.4% in a two-year evaluation, similar to 95% of ceramic veneers in the same study. Meijering et al. reported an absolute survival rate of 74% (including absolute and relative failures as endpoints. A retrospective study by Mazzeti et al. described an annual failure rate (AFR) of 9.1% for 5 years and 10% for 10 years. Greisnig et al. (2012) described a survival rate of 87.5% for composite veneers in 3 years and a half, using the USPHS modified method.
A survival rate of 92.86% for class IV restorations was reported for a 4-year evaluation of paste composite resin restorations. Demirci et al. (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 Meier estimate of 9.9 years showed a survival rate of 74.4% for composite resins used in a class IV cavity.
This single-site, non-randomized, clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will follow a Fédération Dentaire Internationale (FDI) modified score used in previous studies. The last version of the modified FDI score was published in 2023, with an update improving the clarity on scoring the composite restorations. This version of the modified FDI score will be applied in our study. Paste composite survival rates reported by literature are the standard of care for the performance of the flowable composite resin used in our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class IV Restoration | Experimental | Device: 3MTM FiltekTM Supreme Flowable Composite3MTM FiltekTM Supreme Flowable Composites in class IV restoration |
| Veneers | Experimental | Device: 3MTM FiltekTM Supreme Flowable Composite3MTM FiltekTM Supreme Flowable Composites in veneers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 -75 years old
- must be willing and able to provide informed consent to participate in the study
- must be available for the required post-operative follow-up study visits
- must be in good general health
- must be in good oral health hygiene (FMPS < 20%)
Key exclusion criteria (19 listed)
- Single tooth veneers
- Canines
- Periodontal disease
- Pulpal diseases
- Occlusal dysfunctions (end-to-end bite)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3MTM FiltekTM Supreme Flowable Composite3M ™ Supreme Flowable Restorative contains BisGMA,TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non/aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). 3M (TM) Filtek(TM) Supreme Flowable Restorative is a modification of predicate device 3M(TM) Filtek(TM) XT Flowable Restorative (which was a modification of 3M(TM) Filtek(TM) Flow. 3M Filtek Supreme Flowable Composites are used per indication and its approved labeling in this study. | Device | Class IV Restoration, Veneers |
Primary outcome
Survival of treated site over 24 months
Time frame: 24 months
Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.
2 secondary outcomes
Esthetic Properties evaluation
Time frame: 24 months
Functional Properties evaluation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 36744374Ricci WA, Fahl N Jr. Nature-mimicking layering with composite resins through a bio-inspired analysis: 25 years of the polychromatic technique. J Esthet Restor Dent. 2023 Jan;35(1):7-18. doi: 10.1111/jerd.13021. Epub 2023 Feb 6.
- Background: PubMed 31061994Pontons-Melo JC, Atzeri G, Collares FM, Hirata R. Cosmetic recontouring for achieving anterior esthetics. Int J Esthet Dent. 2019;14(2):134-146.
- Background: PubMed 9002903Dietschi D. Free-hand composite resin restorations: a key to anterior aesthetics. Pract Periodontics Aesthet Dent. 1995 Sep;7(7):15-25; quiz 27.
- Background: PubMed 21477031Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.
- Background: PubMed 26177219Hirata R, Kabbach W, de Andrade OS, Bonfante EA, Giannini M, Coelho PG. Bulk Fill Composites: An Anatomic Sculpting Technique. J Esthet Restor Dent. 2015 Nov-Dec;27(6):335-43. doi: 10.1111/jerd.12159. Epub 2015 Jul 14.
- Background: PubMed 29102158Cieplik F, Scholz KJ, Tabenski I, May S, Hiller KA, Schmalz G, Buchalla W, Federlin M. Flowable composites for restoration of non-carious cervical lesions: Results after five years. Dent Mater. 2017 Dec;33(12):e428-e437. doi: 10.1016/j.dental.2017.09.012. Epub 2017 Nov 6.
- Background: PubMed 33797635Zhang H, Wang L, Hua L, Guan R, Hou B. Randomized controlled clinical trial of a highly filled flowable composite in non-carious cervical lesions: 3-year results. Clin Oral Investig. 2021 Oct;25(10):5955-5965. doi: 10.1007/s00784-021-03901-z. Epub 2021 Apr 2.
- Background: PubMed 35556174Endo Hoshino IA, Fraga Briso AL, Bueno Esteves LM, Dos Santos PH, Meira Borghi Frascino S, Fagundes TC. Randomized prospective clinical trial of class II restorations using flowable bulk-fill resin composites: 4-year follow-up. Clin Oral Investig. 2022 Sep;26(9):5697-5710. doi: 10.1007/s00784-022-04526-6. Epub 2022 May 13.
- Background: PubMed 24769385Rocha Gomes Torres C, Rego HM, Perote LC, Santos LF, Kamozaki MB, Gutierrez NC, Di Nicolo R, Borges AB. A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations. J Dent. 2014 Jul;42(7):793-9. doi: 10.1016/j.jdent.2014.04.009. Epub 2014 Apr 25.
- Background: PubMed 32101498Coachman C, De Arbeloa L, Mahn G, Sulaiman TA, Mahn E. An Improved Direct Injection Technique With Flowable Composites. A Digital Workflow Case Report. Oper Dent. 2020 May/Jun;45(3):235-242. doi: 10.2341/18-151-T. Epub 2020 Feb 26.
- Background: PubMed 32918395Ypei Gia NR, Sampaio CS, Higashi C, Sakamoto A Jr, Hirata R. The injectable resin composite restorative technique: A case report. J Esthet Restor Dent. 2021 Apr;33(3):404-414. doi: 10.1111/jerd.12650. Epub 2020 Sep 11.
- Background: PubMed 30265868Imai A, Takamizawa T, Sugimura R, Tsujimoto A, Ishii R, Kawazu M, Saito T, Miyazaki M. Interrelation among the handling, mechanical, and wear properties of the newly developed flowable resin composites. J Mech Behav Biomed Mater. 2019 Jan;89:72-80. doi: 10.1016/j.jmbbm.2018.09.019. Epub 2018 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth L Allen, DDS principal investigator
NYU College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3MTM FiltekTM Supreme Flowable Composite in people with Dental Restoration and Dental Veneers, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Bucovsky (2129989389, mb10357@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of treated site over 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128589, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.