Primary Dental Caries, Multisurface Origin (Diagnosis)NCT04975321
Clinical Trial NuSmile Crowns
A study testing Nu Smile Zirconia crown, Nu Smile Pre Veneered crown and Composite strip crown in people with Primary Dental Caries, Multisurface Origin (Diagnosis), run by University of Washington at 1 site in United States.
Trial summary
A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Dental Caries, Multisurface Origin (Diagnosis)
- What is being tested?
- Nu Smile Zirconia crown, Nu Smile Pre Veneered crown and Composite strip crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2015to 19 Jul 2019
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of record at the University of Washington's Center for Pediatric Dentistry
- Patients in general good health (ASA I)
- Patients aged 5 years old or younger
- Patients in need of at least one preformed crowns, on anterior primary teeth
- Patients undergoing general anesthesia for dental treatment
- Parent or guardian of patient able and willing to provide informed consent
Who cannot join
- Medically compromising condition
- Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
- Teeth with complete absence of facial or lingual walls following tooth preparation
- Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
- Anterior crowding
- Occlusion class III
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington-The Center for Pediatric Dentistry
Seattle, Washington, 98115
About this study
Official title: A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study
A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.
Read the detailed description
Stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. These crowns are silver in color, and aesthetically are not a good option for restoring front teeth. Several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. With the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: NuSmile Signature crowns, NuSmile ZR crowns, and composite crowns. The investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. The purpose of this pilot study is to evaluate the clinical performance of two types of NuSmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.
- Being tested
- Nu Smile Zirconia crown, Nu Smile Pre Veneered crown, Composite strip crown
- Keywords
- Anterior primary teeth restorations
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nu Smile Zirconia crownDevice
Placement of an anterior primary crown restoration
Nu Smile Pre Veneered crownDevice
Placement of an anterior primary crown restoration
Composite strip crownDevice
Placement of an anterior primary crown restoration
| Study group | Role | What they receive |
|---|---|---|
| Nu Smile Zirconia crown | Active comparator | Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Receives: Device: Nu Smile Zirconia crown |
| Nu Smile pre veneered crown | Active comparator | Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration Receives: Device: Nu Smile Pre Veneered crown |
| Composite strip crown | Active comparator | Anterior primary teeth which received a composite strip crown as a final restoration Receives: Device: Composite strip crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitting
The number of teeth scored in the crown fitting categories described below
Fitting 0 = Good natural retention
- Moderate natural retention
- Little or no natural retention
A higher score means a worse outcome
Measured: 12 months
Positioning
Change in the following clinical assessment measure between baseline and 12 months using the categories below
Positioning
0= Proper position
- Rotated - in occlusion
- Not in occlusion with or without rotation
A higher score means a worse outcome
Measured: 12 months
Proximal Contact
The number of teeth scored in the proximal contact categories as described below
Proximal contact 0= Open spaces
- Floss meets little or no resistance when passes through contact
- Floss meets significant when passes through contact
A higher score means a worse outcome
Measured: 12 months
Marginal Adaptation
The number of teeth scored in the marginal adaptation categories as described below
Marginal adaptation 0= No discrepancies detected with explorer
- Detectable discrepancies but clinically acceptable
- Detectable discrepancies, not acceptable -replacement required
A higher score means a worse outcome
Measured: 12 months
Color
The number of teeth scored in the color categories described below
Color matching
0= Matches completely or within range of shade and translucency
- Outside range for yellow, yellow/brown discoloration or gray discoloration
- Outside range for reason other than yellowing or graying
A higher score means a worse outcome
Measured: 12 months
Gingival Status
The number of teeth scored in the gingival status categories described below
Gingival status 0=Pink, firm, free of inflammation
- Red and/or inflamed - no bleeding on probing
- Spontaneous and excessive bleeding on probing
A higher score means a worse outcome
Measured: 12 months
Retention of the Crown
The number of teeth scored in the retention of the crown categories described below
Retention of the crown 0= Intact
1= Partially missing 2 = Missing - some cement remaining on both tooth and crown interior
A higher score means a worse outcome
Measured: 12 months
Integrity of the Veneer/Composite
The number of teeth scored in the integrity of the veneer/composite categories described below
Integrity of veneer/ composite 0= Intact
- Partially missing - one third missing
- Completely missing
A higher score means a worse outcome
Measured: 12 months
Secondary Caries
The number of teeth scored in the secondary caries categories described below
Secondary caries 0= Absent
1= Present
A higher score means a worse outcome
Measured: 12 months
History of Trauma
The number of teeth scored in the history of trauma categories described below
History of trauma 0= Absent
1= Present
A higher score means a worse outcome
Measured: 12 months
Clinical Pulp Pathology
The number of teeth scored in the clinical pulp pathology categories described below
Clinical pulp pathology 0= Absent
1= Present
A higher score means a worse outcome
Measured: 12 months
Radiographical Pulp Pathology
The number of teeth scored in the radiographical pulp pathology categories described below Radiographical pulp pathology 0= Absent
1= Present A higher score means a worse outcome A higher score means a worse outcome
Measured: 12 months
Parent's Esthetic Satisfaction
The number of teeth scored in the parent's esthetic satisfaction categories described below
Parents esthetic satisfaction via a survey 0=Satisfied
1= Dissatisfied
A higher score means a worse outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start6 Jun 2015
- Primary completion16 Oct 2018
- Study completion19 Jul 2019
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 Primary Dental Caries, Multisurface Origin (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariella Garcia, University of Washington
- Investigators
- Mariella Garcia, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975321
- Sponsor's protocol ID
- STUDY00003980
- Status last verified
- Apr 2022
- First submitted
- 1 Jun 2021
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study
- ClinicalTrials.gov ID
- NCT04975321
- Acronym / sponsor ID
- STUDY00003980
- Keywords
- Anterior primary teeth restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 6 Jun 2015 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.
Detailed description
Stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. These crowns are silver in color, and aesthetically are not a good option for restoring front teeth. Several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. With the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: NuSmile Signature crowns, NuSmile ZR crowns, and composite crowns. The investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. The purpose of this pilot study is to evaluate the clinical performance of two types of NuSmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nu Smile Zirconia crown | Active comparator | Device: Nu Smile Zirconia crownAnterior primary teeth which received a NuSmile zirconia crown as a final restoration |
| Nu Smile pre veneered crown | Active comparator | Device: Nu Smile Pre Veneered crownAnterior primary teeth which received a NuSmile pre veneered crown as a final restoration |
| Composite strip crown | Active comparator | Device: Composite strip crownAnterior primary teeth which received a composite strip crown as a final restoration |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients of record at the University of Washington's Center for Pediatric Dentistry
- Patients in general good health (ASA I)
- Patients aged 5 years old or younger
- Patients in need of at least one preformed crowns, on anterior primary teeth
- Patients undergoing general anesthesia for dental treatment
Key exclusion criteria (6 listed)
- Medically compromising condition
- Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
- Teeth with complete absence of facial or lingual walls following tooth preparation
- Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
- Anterior crowding
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 |
|---|---|---|
| Nu Smile Zirconia crownPlacement of an anterior primary crown restoration | Device | Nu Smile Zirconia crown |
| Nu Smile Pre Veneered crownPlacement of an anterior primary crown restoration | Device | Nu Smile pre veneered crown |
| Composite strip crownPlacement of an anterior primary crown restoration | Device | Composite strip crown |
Primary outcome
Fitting
Time frame: 12 months
The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention 1. Moderate natural retention 2. Little or no natural retention A higher score means a worse outcome
Positioning
Time frame: 12 months
Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position 1. Rotated - in occlusion 2. Not in occlusion with or without rotation A higher score means a worse outcome
Proximal Contact
Time frame: 12 months
The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces 1. Floss meets little or no resistance when passes through contact 2. Floss meets significant when passes through contact A higher score means a worse outcome
Marginal Adaptation
Time frame: 12 months
The number of teeth scored in the marginal adaptation categories as described below Marginal adaptation 0= No discrepancies detected with explorer 1. Detectable discrepancies but clinically acceptable 2. Detectable discrepancies, not acceptable -replacement required A higher score means a worse outcome
Color
Time frame: 12 months
The number of teeth scored in the color categories described below Color matching 0= Matches completely or within range of shade and translucency 1. Outside range for yellow, yellow/brown discoloration or gray discoloration 2. Outside range for reason other than yellowing or graying A higher score means a worse outcome
Gingival Status
Time frame: 12 months
The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation 1. Red and/or inflamed - no bleeding on probing 2. Spontaneous and excessive bleeding on probing A higher score means a worse outcome
Retention of the Crown
Time frame: 12 months
The number of teeth scored in the retention of the crown categories described below Retention of the crown 0= Intact 1= Partially missing 2 = Missing - some cement remaining on both tooth and crown interior A higher score means a worse outcome
Integrity of the Veneer/Composite
Time frame: 12 months
The number of teeth scored in the integrity of the veneer/composite categories described below Integrity of veneer/ composite 0= Intact 1. Partially missing - one third missing 2. Completely missing A higher score means a worse outcome
Secondary Caries
Time frame: 12 months
The number of teeth scored in the secondary caries categories described below Secondary caries 0= Absent 1= Present A higher score means a worse outcome
History of Trauma
Time frame: 12 months
The number of teeth scored in the history of trauma categories described below History of trauma 0= Absent 1= Present A higher score means a worse outcome
Clinical Pulp Pathology
Time frame: 12 months
The number of teeth scored in the clinical pulp pathology categories described below Clinical pulp pathology 0= Absent 1= Present A higher score means a worse outcome
Radiographical Pulp Pathology
Time frame: 12 months
The number of teeth scored in the radiographical pulp pathology categories described below Radiographical pulp pathology 0= Absent 1= Present A higher score means a worse outcome A higher score means a worse outcome
Parent's Esthetic Satisfaction
Time frame: 12 months
The number of teeth scored in the parent's esthetic satisfaction categories described below Parents esthetic satisfaction via a survey 0=Satisfied 1= Dissatisfied A higher score means a worse outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mariella Garcia, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nu Smile Zirconia crown, Nu Smile Pre Veneered crown and Composite strip crown in people with Primary Dental Caries, Multisurface Origin (Diagnosis), run by University of Washington 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 6 inclusion and 6 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 9 May 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?
Yes. Results are posted in the registry (first posted 9 May 2022). 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?
Fitting (time frame: 12 months). The study lists 13 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 9 May 2022.