NCT03032705 is a NA clinical trial of SonicFill™ 2 in Dental Caries, sponsored by Tufts University.

Who is sponsoring NCT03032705?

NCT03032705 is sponsored by Tufts University.

What drugs are being tested in NCT03032705?

Interventions in NCT03032705: SonicFill™ 2, Filtek™ Supreme.

What condition does NCT03032705 study?

NCT03032705 studies Dental Caries.

Is NCT03032705 still recruiting?

NCT03032705 is currently completed. Last updated 13 December 2021.

Are results published for NCT03032705?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-13 · How we verify

NCT03032705

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative

Completed NA Results posted Last updated 13 December 2021

What this trial tests

NA trial testing SonicFill™ 2 in Dental Caries in 51 participants. Completed in 5 February 2020.

Timeline

19 June 2017

Primary endpoint
5 February 2020

5 February 2020

Quick facts

Lead sponsor	Tufts University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	51
Start date	19 June 2017
Primary completion	5 February 2020
Estimated completion	5 February 2020
Sites	1 location across United States

Drugs / interventions tested

SonicFill™ 2
Filtek™ Supreme

Conditions studied

Dental Caries — all drugs for Dental Caries →

Sponsor

Tufts University

Who can join

18 and older, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category Primary · From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Surface Luster at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	25
Filtek™ Supreme	25

Surface Luster at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	2
Filtek™ Supreme	2

Surface Luster at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Surface Luster at end of study : Number of teeth rated 4

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	0

Surface Luster at end of study : Number of teeth rated 5

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Surface Staining at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	26
Filtek™ Supreme	22

Surface Staining at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	3

Surface Staining at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	2

Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category Primary · From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria: 1. Fracture of material and retention 2. Marginal adaptation 3. Approximate anatomical form - contact point 4. Radio-graphic examination (when applicable) 5. Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Fracture of Material and Retention at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	27
Filtek™ Supreme	26

Fracture of Material and Retention at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	1

Fracture of Material and Retention at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	0

Fracture of Material and Retention at end of study : Number of teeth rated 4

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Fracture of Material and Retention at end of study : Number of teeth rated 5

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Marginal Adaptation at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	23
Filtek™ Supreme	25

Marginal Adaptation at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	5
Filtek™ Supreme	2

Marginal Adaptation at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category Primary · From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria: 1. Postoperative (hyper-)sensitivity and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	27
Filtek™ Supreme	27

Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	0

Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1

Group	Value	95% CI
SonicFill™ 2	27
Filtek™ Supreme	27

Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2

Group	Value	95% CI
SonicFill™ 2	1
Filtek™ Supreme	0

Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3

Group	Value	95% CI
SonicFill™ 2	0
Filtek™ Supreme	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, an average of 24 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SonicFill™ 2

Serious: 0/51 (0%)

Deaths: 0/51

Filtek™ Supreme

Serious: 0/51 (0%)

Deaths: 0/51

Other adverse events (4 terms — click to expand)

Reaction	System	SonicFill™ 2	Filtek™ Supreme
Post operative sensitivity/Pain	Injury, poisoning and procedural complications	—	—
Pulp exposure risk, healing of non- study site, Alterantion of study site due to non-study site tx	General disorders	—	—
Fracture of restorations	Product Issues	—	—
Soft tissue irritation	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03032705 adverse events section.

Sponsor's own description

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities. In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Dental Caries

Currently open trials in the same condition.

NCT06787261 — Involvement of Archaea in Carious Disease · NA · recruiting
NCT06753669 — Mothers' Action Project for Child Health · NA · recruiting
NCT07431463 — Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary T · NA · active not recruiting
NCT07134114 — Occlusal Impact of Hall Crowns in Primary Molars · NA · recruiting
NCT07181967 — SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children · NA · recruiting

Other Tufts University trials

Trials by the same sponsor.

NCT07249242 — Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments · NA · recruiting
NCT07099131 — Effective Interventions to Overcome Severe Gag Reflex · EARLY_PHASE1 · not yet recruiting
NCT06428630 — Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus · EARLY_PHASE1 · withdrawn
NCT06526221 — Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India · NA · not yet recruiting
NCT06352645 — Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03032705 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tufts University
Last refreshed: 13 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03032705.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing