Dental CariesNCT01919515
Trial of a New NuSmile ZR Esthetic Primary Molar Crown
A study testing ZR Crown and Stainless Steel Crown in people with Dental Caries, run by NuSmile, Ltd. at 2 sites in United States.
Trial summary
The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- ZR Crown and Stainless Steel Crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Jun 2017
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 3 and 7 years of age
- Have a minimum of two primary molar teeth, requiring crowns
- Have a parent or guardian capable of giving written informed consent
- Have study teeth in occlusion and in contact with adjacent teeth
- Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.
Who cannot join
- Tooth is considered to be within 36 months of exfoliation
- They have a severe / serious childhood illness that requires frequent hospitalization
- They have poor general health
- They have juvenile periodontitis
- Patient is unable to return for evaluations / study recalls
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Health Science Center-Dental School
San Antonio, Texas, 78229
The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
San Antonio, Texas, 78237
About this study
Official title: Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
Read the detailed description
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.
- Conditions
- Dental Caries
- Being tested
- ZR Crown, Stainless Steel Crown
- Keywords
- pediatric, primary molars, stainless steel crowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZR CrownDevice
This is an esthetic primary molar crown.
Stainless Steel CrownDevice
This is a conventional stainless steel crown.
| Study group | Role | What they receive |
|---|---|---|
| ZR Crown & Stainless Steel Crown | Other | Each subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown. Receives: Device: ZR Crown; Device: Stainless Steel Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of the SSC and ZR Crown
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.
Measured: At Baseline
Assessments of the SSC and ZR Crown at 6 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 6 month visit
Assessments of the SSC and ZR Crown at 12 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 12 month visit
Assessments of the SSC and ZR Crown at 18 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 18 month visit
Assessments of the SSC and ZR Crown at 24 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 24 month visit
Assessments of SSC and ZR Crown at 36 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 36 month visit
Assessments of SSC and ZR Crowns at 48 months
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Measured: 48 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuSmile, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin J. Donly, D.D.S., M.S., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919515
- Sponsor's protocol ID
- 20130203
- Status last verified
- Oct 2014
- First submitted
- 31 Jul 2013
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
PubMed 6935165
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
- ClinicalTrials.gov ID
- NCT01919515
- Acronym / sponsor ID
- 20130203
- Conditions
- Dental Caries
- Keywords
- pediatric, primary molars, stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NuSmile, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2017 (estimated)
- First posted
- 9 Aug 2013 (estimated)
- 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 hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
Detailed description
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZR Crown & Stainless Steel Crown | Other | Device: ZR Crown, Device: Stainless Steel CrownEach subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be between 3 and 7 years of age
- Have a minimum of two primary molar teeth, requiring crowns
- Have a parent or guardian capable of giving written informed consent
- Have study teeth in occlusion and in contact with adjacent teeth
- Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.
Key exclusion criteria (5 listed)
- Tooth is considered to be within 36 months of exfoliation
- They have a severe / serious childhood illness that requires frequent hospitalization
- They have poor general health
- They have juvenile periodontitis
- Patient is unable to return for evaluations / study recalls
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 |
|---|---|---|
| ZR CrownThis is an esthetic primary molar crown. | Device | ZR Crown & Stainless Steel Crown |
| Stainless Steel CrownThis is a conventional stainless steel crown. | Device | ZR Crown & Stainless Steel Crown |
Primary outcome
Assessments of the SSC and ZR Crown
Time frame: At Baseline
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.
Assessments of the SSC and ZR Crown at 6 months
Time frame: 6 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 12 months
Time frame: 12 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 18 months
Time frame: 18 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 24 months
Time frame: 24 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crown at 36 months
Time frame: 36 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crowns at 48 months
Time frame: 48 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 6935165Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
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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.
Kevin J. Donly, D.D.S., M.S. principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZR Crown and Stainless Steel Crown in people with Dental Caries, run by NuSmile, Ltd. at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Assessments of the SSC and ZR Crown (time frame: At Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919515, which also lists 2 linked publications.
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 8 Oct 2014.