Clinical Evaluation of a Bulk Fill Resin Composite

September 26, 2025 updated by: Ivoclar Vivadent AG
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • UAB School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tetric PowerFill Class I and II restorations
Device: Tetric PowerFill
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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"
Baseline
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")
Baseline
Overall Survival Rate
Time Frame: Baseline
Restorations were examined by a dentist
Baseline
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"
6 Month
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")
6 Month
Overall Survival Rate
Time Frame: 6 Month
Restorations were examined by a dentist
6 Month
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"
12 Month
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")
12 Month
Overall Survival Rate
Time Frame: 12 Month
Restorations were examined by a dentist
12 Month
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"
24 Month
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")
24 Month
Overall Survival Rate
Time Frame: 24 Month
Restorations were examined by a dentist
24 Month
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"
36 Month
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")
36 Month
Overall Survival Rate
Time Frame: 36 Month
Restorations were examined by a dentist
36 Month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time Frame: Baseline
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Baseline
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time Frame: 6 Month
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
6 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time Frame: 12 Month
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
12 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time Frame: 24 Month
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
24 Month
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
Time Frame: 36 Month
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
36 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ivoclar Vivadent AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathaniel Lawson, Dr, UAB School of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LL3079573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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