CariesNCT04708223
Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite
A study testing Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) and Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill) in people with Caries and Defective Tooth Restorations, run by Ivoclar Vivadent AG at 1 site in United States.
Trial summary
The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Caries, Defective Tooth Restorations
- What is being tested?
- Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) and Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 16 May 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
- Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
- Must have given written consent to participate in the trial
- Must be available for the required follow-up visits over 2 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 16Show fewer
- 75% of the restorations Class II (minimum) and 25% Class I
- One, two or three surfaces per restoration
- 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 with evidence of bilateral posterior tooth contacts
- Teeth that require one or no cuspal build-ups
- Vital tooth
- Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum)
- Patient wishes to be treated in this clinical trial after oral information by the operator and after signing the informed patient form
Who cannot join
- Allergies to ingredients of the materials under investigation (monomers)
- Do not meet all inclusion criteria above
- Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene
- Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects
- 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 10Show fewer
- Patients reporting having severe grinding/bruxing or clenching or in need of TMJ-related therapy
- Have tooth with exposed pulp during preparation or caries removal or require indirect pulp capping
- Inclusion of teeth that are non-vital or that exhibit signs of pulpal pathology (pulpitis)
- If the working field cannot be maintained in a dry state for treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois College of Dentistry
Chicago, Illinois, 60612
About this study
Official title: A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite
The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.
Read the detailed description
Patients, requiring posterior tooth restorations Class I and II or requesting amalgam restoration replacement, were treated in the clinical investigation. Each patient received two composite restorations in the posterior region.
- Conditions
- Caries, Defective Tooth Restorations
- Being tested
- Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow), Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)Device
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)Device
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
| Study group | Role | What they receive |
|---|---|---|
| Fast-curing composites | Experimental | Not described Receives: Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) |
| Conventionally applied composites | Other | Not described Receives: Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Teeth Analyzed According to 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 Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"
Measured: Baseline
Number of Teeth Analyzed According to 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
Number of Teeth Analyzed According to 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
Number of Teeth Analyzed According to 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
Number of Teeth Analyzed According to 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
Secondary outcomes (5)
Restoration Quality Evaluation
assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Measured: Baseline
Restoration Quality Evaluation
assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Measured: 6 Month
Restoration Quality Evaluation
assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Measured: 12 Month
Restoration Quality Evaluation
assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Measured: 24 Month
Restoration Quality Evaluation
assessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) 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.
- First posted13 Jan 2021
- Study start1 Sep 2018
- Primary completion16 May 2022
- Study completion16 May 2022
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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth Design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon F. Cooper, Dr., Principal investigator, University of Illinois College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708223
- Sponsor's protocol ID
- LL3274680
- Status last verified
- May 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
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
- A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite
- ClinicalTrials.gov ID
- NCT04708223
- Acronym / sponsor ID
- LL3274680
- Conditions
- Caries, Defective Tooth Restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.
Detailed description
Patients, requiring posterior tooth restorations Class I and II or requesting amalgam restoration replacement, were treated in the clinical investigation. Each patient received two composite restorations in the posterior region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth Design
| Arm | Type | Receives |
|---|---|---|
| Fast-curing composites | Experimental | Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) |
| Conventionally applied composites | Other | Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
- Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
- Must have given written consent to participate in the trial
- Must be available for the required follow-up visits over 2 years
- Restored teeth must have occlusal contact with opposing teeth or restored teeth
Key exclusion criteria (10 listed)
- Allergies to ingredients of the materials under investigation (monomers)
- Do not meet all inclusion criteria above
- Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene
- Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects
- 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 |
|---|---|---|
| Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s. | Device | Fast-curing composites |
| Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment. | Device | Conventionally applied composites |
Primary outcome
Number of Teeth Analyzed According to 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 Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"
Number of Teeth Analyzed According to 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"
Number of Teeth Analyzed According to 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"
Number of Teeth Analyzed According to 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"
Number of Teeth Analyzed According to 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"
5 secondary outcomes
Restoration Quality Evaluation
Time frame: Baseline
Restoration Quality Evaluation
Time frame: 6 Month
Restoration Quality Evaluation
Time frame: 12 Month
Restoration Quality Evaluation
Time frame: 24 Month
Restoration Quality Evaluation
Time frame: 36 Month
Results and safety
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.
Lyndon F. Cooper, Dr. principal investigator
University of Illinois 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 Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) and Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill) in people with Caries and Defective Tooth Restorations, 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 16 inclusion and 10 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 5 Jun 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?
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.