Dental CariesNCT04686422

Clinical Evaluation of a Bulk Fill Resin Composite

A study testing Tetric PowerFill in people with Dental Caries and Unsatisfactory or Defective Restoration of Tooth, run by Ivoclar Vivadent AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Dental Caries, Unsatisfactory or Defective Restoration of Tooth
What is being tested?: Tetric PowerFill
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2017to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Each subject must need at least 1 restoration in a vital posterior tooth
Must have given written consent to participate in the trial
Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable
Must be available for the required follow-up visits over 3 years
Restored teeth must have occlusal contact with opposing teeth or restored teeth
Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips

Show all 11Show fewer

75% of the restorations Class II (minimum) and 25% Class I
Each Class II will have at least one proximal contact
75% in molars (minimum) and 25% in premolars
All restored teeth must have at least one occlusal contact in habitual closure
Must have 20 or more teeth

Who cannot join

If they have an allergy to ingredients of the materials under investigation (monomers)
Do not meet all inclusion criteria above
Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
Have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries.
Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
Present with any systemic or local disorders that contraindicate the dental procedures included in this study

Show all 11Show fewer

Have unstable occlusion
Have severe grinding/bruxing or clenching or need TMJ-related therapy
Have tooth with exposed pulp during preparation or caries removal
Teeth that are non-vital or that exhibit signs of pulpal pathology for restoration
Teeth that require cuspal build-ups involving more than one cusp

Trial locations and contacts

1 site in 1 country.

United States1 site

UAB School of Dentistry
Birmingham, Alabama, 35294-0007

Other trials in United States

About this study

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.

Conditions: Dental Caries, Unsatisfactory or Defective Restoration of Tooth
Being tested: Tetric PowerFill
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tetric PowerFillDevice
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.

Study groups in NCT04686422
Study group	Role	What they receive
Tetric PowerFill Class I and II restorations	Experimental	Not described Receives: Device: Tetric PowerFill

What is being measured

The primary outcome is the main question the study is designed to answer.

FDI 11 - Postoperative Hypersensitivity
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"
Measured: Baseline
Pulp Integrity
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")
Measured: Baseline
Overall Survival Rate
Restorations were examined by a dentist
Measured: Baseline
FDI 11 - Postoperative Hypersensitivity
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"
Measured: 6 Month
Pulp Integrity
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")
Measured: 6 Month
Overall Survival Rate
Restorations were examined by a dentist
Measured: 6 Month
FDI 11 - Postoperative Hypersensitivity
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"
Measured: 12 Month
Pulp Integrity
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")
Measured: 12 Month
Overall Survival Rate
Restorations were examined by a dentist
Measured: 12 Month
FDI 11 - Postoperative Hypersensitivity
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"
Measured: 24 Month
Pulp Integrity
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")
Measured: 24 Month
Overall Survival Rate
Restorations were examined by a dentist
Measured: 24 Month
FDI 11 - Postoperative Hypersensitivity
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"
Measured: 36 Month
Pulp Integrity
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")
Measured: 36 Month
Overall Survival Rate
Restorations were examined by a dentist
Measured: 36 Month

Secondary outcomes (5)

FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: Baseline
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: 6 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: 12 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: 24 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: 36 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201730 Jun 2021

First posted28 Dec 2020
Study start1 Dec 2017
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental CariesStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04686422
Sponsor's protocol ID: LL3079573
Status last verified: Apr 2025
First submitted: 22 Dec 2020
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Bulk Fill Resin Composite
ClinicalTrials.gov ID: NCT04686422
Acronym / sponsor ID: LL3079573
Conditions: Dental Caries, Unsatisfactory or Defective Restoration of Tooth
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
Study start: 1 Dec 2017 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 28 Dec 2020 (actual)
Results: Posted 2 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tetric PowerFill Class I and II restorations	Experimental	Device: Tetric PowerFill

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Each subject must need at least 1 restoration in a vital posterior tooth
Must have given written consent to participate in the trial
Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable
Must be available for the required follow-up visits over 3 years
Restored teeth must have occlusal contact with opposing teeth or restored teeth

Key exclusion criteria (11 listed)

If they have an allergy to ingredients of the materials under investigation (monomers)
Do not meet all inclusion criteria above
Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
Have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries.
Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored

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
Tetric PowerFillTooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.	Device	Tetric PowerFill Class I and II restorations

Primary outcome

FDI 11 - Postoperative Hypersensitivity
Time frame: 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"
Pulp Integrity
Time frame: 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")
Overall Survival Rate
Time frame: Baseline
Restorations were examined by a dentist
FDI 11 - Postoperative Hypersensitivity
Time frame: 6 Month
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"
Pulp Integrity
Time frame: 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")
Overall Survival Rate
Time frame: 6 Month
Restorations were examined by a dentist
FDI 11 - Postoperative Hypersensitivity
Time frame: 12 Month
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"
Pulp Integrity
Time frame: 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")
Overall Survival Rate
Time frame: 12 Month
Restorations were examined by a dentist
FDI 11 - Postoperative Hypersensitivity
Time frame: 24 Month
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"
Pulp Integrity
Time frame: 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")
Overall Survival Rate
Time frame: 24 Month
Restorations were examined by a dentist
FDI 11 - Postoperative Hypersensitivity
Time frame: 36 Month
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"
Pulp Integrity
Time frame: 36 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")
Overall Survival Rate
Time frame: 36 Month
Restorations were examined by a dentist

5 secondary outcomes

FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time frame: Baseline
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time frame: 6 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time frame: 12 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time frame: 24 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time frame: 36 Month

Results and safety

Results posted to the registry on 2 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tetric PowerFill Class I and II restorations	39	23

Primary outcome: FDI 11 - Postoperative Hypersensitivity

Time frame: Baseline. Number. Unit: Restorations

Measure	Tetric PowerFill Class I and II restorations n = 39
FDI Score 1	55
FDI Score 2	10
FDI Score 3	3
FDI Score 4-5	0

Primary outcome: Pulp Integrity

Time frame: Baseline. Number. Unit: Restorations

Measure	Tetric PowerFill Class I and II restorations n = 39
VAS Score 0-1	60
VAS Score 2-3	5
VAS Score 4-6	2
VAS Score 7-8	0
VAS Score 9-10	1

Primary outcome: Overall Survival Rate

Time frame: Baseline. Number. Unit: Restorations

Measure	Tetric PowerFill Class I and II restorations n = 39
Value	68

Primary outcome: FDI 11 - Postoperative Hypersensitivity

Time frame: 6 Month. Number. Unit: Restorations

Measure	Tetric PowerFill Class I and II restorations n = 37
FDI Score 1	60
FDI Score 2	3
FDI Score 3	3
FDI Score 4-5	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tetric PowerFill Class I and II restorations	0 of 39 (0%)	2 of 39 (5.1%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Nathaniel Lawson, Dr principal investigator

UAB School 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 Tetric PowerFill in people with Dental Caries and Unsatisfactory or Defective Restoration of Tooth, run by Ivoclar Vivadent AG 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 23 Oct 2025. 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?

Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FDI 11 - Postoperative Hypersensitivity (time frame: Baseline). The study lists 15 primary outcomes in all. 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 NCT04686422.

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 23 Oct 2025.