Dental CariesNCT03032705
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
A study testing SonicFill™ 2 and Filtek™ Supreme in people with Dental Caries, run by Tufts University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- SonicFill™ 2 and Filtek™ Supreme
- 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
- 19 Jun 2017to 5 Feb 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age
- Is willing to provide voluntary written informed consent
- Is in good medical health and able to tolerate the dental procedures
- Has at least 1 pair of qualifying molars or premolars that require Class II restorations.
- Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
- Study teeth must be in occlusal function and must also be in contact with the neighboring tooth on at least one surface
- Study teeth must be vital (i.e., free of clinical signs and symptoms of periapical pathology)
Who cannot join
- Is currently taking part in an evaluation of other dental restorative materials
- Has chronic periodontitis or rampant caries
- Teeth exhibiting clinical signs of periapical pathology
- Teeth with a history of self-reported preoperative pulpal problems
- Women who are pregnant (self-reported). It is standard of care to post-pone routine dental procedures and radiographed until after pregnancy.
- Women who are breast feeding.
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- Known allergy to resin composites or local anesthetics.
- Abnormal oral soft tissue findings (e.g., open sores, lesions)
- An employee of the sponsor or members of their immediate family.
- Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
- Any restorative treatment of the teeth involved in the study in the last 12 months.
- Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues
- Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
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.
Read the detailed description
This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique.
The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:
Esthetic Properties
- Surface luster
- Staining - surface
- Staining - margin
- Color match and translucency
- Esthetic anatomical form
Functional Properties
- Fracture of material and retention
- Marginal adaptation
- Approximate anatomical form - contact point
- Radio-graphic examination (when applicable)
- Patient's view
Biological Properties
- Postoperative (hyper-)sensitivity and tooth vitality
- Recurrence of caries, erosion, abfraction
- Tooth integrity (enamel cracks, tooth fractures)
- Adjacent mucosa
The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories
- Conditions
- Dental Caries
- Being tested
- SonicFill™ 2, Filtek™ Supreme
- Keywords
- Restorations, Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonicFill™ 2Device
The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
Filtek™ SupremeDevice
The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
| Study group | Role | What they receive |
|---|---|---|
| SonicFill™ 2 | Experimental | Composite: SonicFill™ 2; Bonding Agent: Optibond XRT Receives: Device: SonicFill™ 2 |
| Filtek™ Supreme | Active comparator | Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Receives: Device: Filtek™ Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
The following properties will be evaluated using the Hickel Grading Criteria:
- Surface luster
- Staining - surface
- Staining - margin
- Color match and translucency
- Esthetic anatomical form
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Measured: From Baseline up to 2 Years After Restoration Placement
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
The following properties will be evaluated using the Hickel Grading Criteria:
- Fracture of material and retention
- Marginal adaptation
- Approximate anatomical form - contact point
- Radio-graphic examination (when applicable)
- Patient's view
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Measured: From Baseline up to 2 Years After Restoration Placement
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
The following properties will be evaluated using the Hickel Grading Criteria:
- Postoperative (hyper-)sensitivity and tooth vitality
- Recurrence of caries, erosion, abfraction
- Tooth integrity (enamel cracks, tooth fractures)
- Adjacent mucosa
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Measured: From Baseline up to 2 Years After Restoration Placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start19 Jun 2017
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- KaVo Kerr
- Responsible party
- Principal investigator, Dr. Gerard Kugel, Tufts University
- Investigators
- Gerard Kugel, DMD, MS, PhD, Principal investigator, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032705
- Sponsor's protocol ID
- 12311
- Status last verified
- Nov 2021
- First submitted
- 19 Jan 2017
- Last updated
- 13 Dec 2021
- 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 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
- ClinicalTrials.gov ID
- NCT03032705
- Acronym / sponsor ID
- 12311
- Conditions
- Dental Caries
- Keywords
- Restorations, Composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- KaVo Kerr
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 12 Nov 2021
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 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.
Detailed description
This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique.
The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:
Esthetic Properties
- Surface luster
- Staining - surface
- Staining - margin
- Color match and translucency
- Esthetic anatomical form
Functional Properties
- Fracture of material and retention
- Marginal adaptation
- Approximate anatomical form - contact point
- Radio-graphic examination (when applicable)
- Patient's view
Biological Properties
- Postoperative (hyper-)sensitivity and tooth vitality
- Recurrence of caries, erosion, abfraction
- Tooth integrity (enamel cracks, tooth fractures)
- Adjacent mucosa
The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SonicFill™ 2 | Experimental | Device: SonicFill™ 2Composite: SonicFill™ 2; Bonding Agent: Optibond XRT |
| Filtek™ Supreme | Active comparator | Device: Filtek™ SupremeComposite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is at least 18 years of age
- Is willing to provide voluntary written informed consent
- Is in good medical health and able to tolerate the dental procedures
- Has at least 1 pair of qualifying molars or premolars that require Class II restorations.
- Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
Key exclusion criteria (13 listed)
- Is currently taking part in an evaluation of other dental restorative materials
- Has chronic periodontitis or rampant caries
- Teeth exhibiting clinical signs of periapical pathology
- Teeth with a history of self-reported preoperative pulpal problems
- Women who are pregnant (self-reported). It is standard of care to post-pone routine dental procedures and radiographed until after pregnancy.
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 |
|---|---|---|
| SonicFill™ 2The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer. | Device | SonicFill™ 2 |
| Filtek™ SupremeThe intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. | Device | Filtek™ Supreme |
Primary outcome
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Time frame: 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
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Time frame: 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
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- 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.
Gerard Kugel, DMD, MS, PhD principal investigator
TUSDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonicFill™ 2 and Filtek™ Supreme in people with Dental Caries, run by Tufts University 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 7 inclusion and 13 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 13 Dec 2021. 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 12 Nov 2021). 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?
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category (time frame: From Baseline up to 2 Years After Restoration Placement). The study lists 3 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 13 Dec 2021.