Non-carious Cervical LesionsNCT03153969
Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
A study testing SHOFU Beautifil II LS and 3M/ESPE Filtek Supreme in people with Non-carious Cervical Lesions, run by Tufts University at 1 site in United States.
Trial summary
The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- SHOFU Beautifil II LS and 3M/ESPE Filtek Supreme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years or older, in general health
- Must have a minimum of 2 cervical lesions in need of restoration
- Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour
- At least 50% of lesion must be in dentin
- Coronal margin of lesion must be in enamel
Who cannot join
- Rampant uncontrolled caries
- Systemic or local disorders that contra-indicate the dental procedures included in this study
- Evidence of xerostomia
- Evidence of severe bruxing or clenching or in need of TMJ related therapy
- Women who are pregnant or breast feeding (self-reported).
- Known allergy to resin composites or local anesthetics
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- Abnormal oral soft tissue findings (e.g., open sores, lesions)
- Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
- Teeth with periapical pathology or exhibiting symptoms of pulpal pathology
- Teeth that are non-vital or have had root canal therapy
- Teeth that have been pulp capped
- Teeth with near exposures on pre-operative radiographs
- Hypersensitive teeth
- Teeth with a periodontal pocket of more than 4mm with bleeding on probing
- Teeth that are used as abutments for removable partial dentures
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: A Clinical Trial to Evaluate a New Giomer Restorative System in Class V Restorations
The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.
3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.
Read more
Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.
In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.
Read the detailed description
This is a single-center, non-blinded, controlled, split mouth, clinical trial 18 months in duration.
The purpose of this clinical trial is to evaluate the effectiveness of a new Giomer restorative system (Shofu Beautifil LS) for use in restoring non carious Class V lesions by comparing it to 3M ESPE FiltekTM Supreme in the following categories:
Clinical Assessments (Documentation at baseline, 6months and 18months):
- Surface Luster
- Surface Staining
- Marginal Staining
- Color Match
- Anatomical Form
- Marginal Adaptation
- Fracture of Material and Retention
- Radiographic Examination
- Patient's View
- Postoperative Hypersensitivity
- Recurrence of Caries
- Tooth Integrity
- Adjacent Mucosa
Sensitivity interview- assessed preoperatively (prior to anesthesia, if needed) at baseline and after restoration placement
Dentin Sclerosis Rating- assessed at baseline
- Conditions
- Non-carious Cervical Lesions
- Being tested
- SHOFU Beautifil II LS, 3M/ESPE Filtek Supreme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHOFU Beautifil II LSDevice
Placed under manufacturer's instructions
3M/ESPE Filtek SupremeDevice
Placed under manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| SHOFU Beautifil II LS | Experimental | Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond Receives: Device: SHOFU Beautifil II LS |
| 3M/ESPE Filtek Supreme | Active comparator | Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal Receives: Device: 3M/ESPE Filtek Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hickel Criteria
Clinical assessments (Esthetic properties: surface luster, surface staining, marginal staining, color match, anatomical form, Functional properties: marginal adaptation, fracture of material and retention, radiographic examination, patient's view, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa) will be performed by two trained examiners other than the operating clinician using modified Hickel criteria at baseline and follow-up visits. Differences between the two groups for Hickel criteria items will be examined with the Wilcoxon signed-rank test.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start28 Aug 2017
- Primary completion30 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-carious Cervical LesionsStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Shofu Inc.
- Responsible party
- Principal investigator, Dr. Gerard Kugel, Tufts University
- Investigators
- Gerard Kugel, DMD, MS, PhD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153969
- Sponsor's protocol ID
- 12486
- Status last verified
- Nov 2022
- First submitted
- 11 May 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate a New Giomer Restorative System in Class V Restorations
- ClinicalTrials.gov ID
- NCT03153969
- Acronym / sponsor ID
- 12486
- Conditions
- Non-carious Cervical Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Shofu Inc.
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
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 study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.
3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.
Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.
In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.
Detailed description
This is a single-center, non-blinded, controlled, split mouth, clinical trial 18 months in duration.
The purpose of this clinical trial is to evaluate the effectiveness of a new Giomer restorative system (Shofu Beautifil LS) for use in restoring non carious Class V lesions by comparing it to 3M ESPE FiltekTM Supreme in the following categories:
Clinical Assessments (Documentation at baseline, 6months and 18months):
- Surface Luster
- Surface Staining
- Marginal Staining
- Color Match
- Anatomical Form
- Marginal Adaptation
- Fracture of Material and Retention
- Radiographic Examination
- Patient's View
- Postoperative Hypersensitivity
- Recurrence of Caries
- Tooth Integrity
- Adjacent Mucosa
Sensitivity interview- assessed preoperatively (prior to anesthesia, if needed) at baseline and after restoration placement
Dentin Sclerosis Rating- assessed at baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHOFU Beautifil II LS | Experimental | Device: SHOFU Beautifil II LSComposite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond |
| 3M/ESPE Filtek Supreme | Active comparator | Device: 3M/ESPE Filtek SupremeComposite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older, in general health
- Must have a minimum of 2 cervical lesions in need of restoration
- Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour
- At least 50% of lesion must be in dentin
- Coronal margin of lesion must be in enamel
Key exclusion criteria (15 listed)
- Rampant uncontrolled caries
- Systemic or local disorders that contra-indicate the dental procedures included in this study
- Evidence of xerostomia
- Evidence of severe bruxing or clenching or in need of TMJ related therapy
- Women who are pregnant or breast feeding (self-reported).
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 |
|---|---|---|
| SHOFU Beautifil II LSPlaced under manufacturer's instructions | Device | SHOFU Beautifil II LS |
| 3M/ESPE Filtek SupremePlaced under manufacturer's instructions | Device | 3M/ESPE Filtek Supreme |
Primary outcome
Hickel Criteria
Time frame: Up to 18 months
Clinical assessments (Esthetic properties: surface luster, surface staining, marginal staining, color match, anatomical form, Functional properties: marginal adaptation, fracture of material and retention, radiographic examination, patient's view, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa) will be performed by two trained examiners other than the operating clinician using modified Hickel criteria at baseline and follow-up visits. Differences between the two groups for Hickel criteria items will be examined with the Wilcoxon signed-rank test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- 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
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHOFU Beautifil II LS and 3M/ESPE Filtek Supreme in people with Non-carious Cervical Lesions, 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 5 inclusion and 15 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 16 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hickel Criteria (time frame: Up to 18 months). 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 16 Nov 2022.