NCT04686422 is a NA clinical trial of Tetric PowerFill in Dental Caries, sponsored by Ivoclar Vivadent AG.

Who is sponsoring NCT04686422?

NCT04686422 is sponsored by Ivoclar Vivadent AG.

What drugs are being tested in NCT04686422?

Interventions in NCT04686422: Tetric PowerFill.

What condition does NCT04686422 study?

NCT04686422 studies Dental Caries, Unsatisfactory or Defective Restoration of Tooth.

Is NCT04686422 still recruiting?

NCT04686422 is currently completed. Last updated 23 October 2025.

Are results published for NCT04686422?

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

Last reviewed 2025-10-23 · How we verify

NCT04686422

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

Clinical Evaluation of a Bulk Fill Resin Composite

Completed NA Results posted Last updated 23 October 2025

What this trial tests

NA trial testing Tetric PowerFill in Dental Caries in 39 participants. Completed in 30 June 2021.

Timeline

1 December 2017

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Ivoclar Vivadent AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	1 December 2017
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

Tetric PowerFill

Conditions studied

Dental Caries — all drugs for Dental Caries →
Unsatisfactory or Defective Restoration of Tooth — all drugs for Unsatisfactory or Defective Restoration of Tooth →

Sponsor

Ivoclar Vivadent AG — full company profile →

Who can join

Adults 19 to 90, any sex, with Dental Caries or Unsatisfactory or Defective Restoration of Tooth. 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.

FDI 11 - Postoperative Hypersensitivity Primary · Baseline

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

FDI Score 1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	55

FDI Score 2

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	10

FDI Score 3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	3

FDI Score 4-5

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Pulp Integrity Primary · Baseline

Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

VAS Score 0-1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	60

VAS Score 2-3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	5

VAS Score 4-6

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	2

VAS Score 7-8

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 9-10

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	1

Overall Survival Rate Primary · Baseline

Restorations were examined by a dentist

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	68

FDI 11 - Postoperative Hypersensitivity Primary · 6 Month

FDI Score 1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	60

FDI Score 2

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	3

FDI Score 3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	3

FDI Score 4-5

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Pulp Integrity Primary · 6 Month

Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

VAS Score 0-1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	64

VAS Score 2-3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 4-6

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 7-8

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 9-10

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	2

Overall Survival Rate Primary · 6 Month

Restorations were examined by a dentist

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	66

FDI 11 - Postoperative Hypersensitivity Primary · 12 Month

FDI Score 1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	59

FDI Score 2

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	2

FDI Score 3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	1

FDI Score 4-5

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Pulp Integrity Primary · 12 Month

Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

VAS Score 0-1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	60

VAS Score 2-3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 4-6

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	2

VAS Score 7-8

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 9-10

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Overall Survival Rate Primary · 12 Month

Restorations were examined by a dentist

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	62

FDI 11 - Postoperative Hypersensitivity Primary · 24 Month

FDI Score 1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	50

FDI Score 2

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	2

FDI Score 3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

FDI Score 4-5

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Pulp Integrity Primary · 24 Month

Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

VAS Score 0-1

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	49

VAS Score 2-3

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	3

VAS Score 4-6

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 7-8

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

VAS Score 9-10

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	0

Overall Survival Rate Primary · 24 Month

Restorations were examined by a dentist

Survived

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	51

Failed

Group	Value	95% CI
Tetric PowerFill Class I and II restorations	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 36 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tetric PowerFill Class I and II restorations

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (1 terms — click to expand)

Reaction	System	Tetric PowerFill Class I a…
Restoration was replaced	General disorders	—

Data from ClinicalTrials.gov NCT04686422 adverse events section.

Sponsor's own description

The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.

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 Ivoclar Vivadent AG trials

Trials by the same sponsor.

NCT06898411 — Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations · not yet recruiting
NCT06238999 — Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions · NA · active not recruiting
NCT06173167 — Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns · NA · recruiting
NCT06166849 — Clinical Evaluation of an Experimental Remineralization Product · NA · completed
NCT06131294 — Efficacy Evaluation of Two Different Fluoride Applications · NA · completed

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 NCT04686422 (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 Ivoclar Vivadent AG
Last refreshed: 23 October 2025

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/NCT04686422.

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

NCT04686422

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Dental Caries

Other Ivoclar Vivadent AG trials

Verify against primary sources