Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nu Smile Zirconia crown | Active Comparator | Anterior primary teeth which received a NuSmile zirconia crown as a final restoration |
|
| Nu Smile pre veneered crown | Active Comparator | Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration |
|
| Composite strip crown | Active Comparator | Anterior primary teeth which received a composite strip crown as a final restoration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nu Smile Zirconia crown | Device | Placement of an anterior primary crown restoration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fitting | The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention
A higher score means a worse outcome | 12 months |
| Positioning | Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position
A higher score means a worse outcome | 12 months |
| Proximal Contact | The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces
A higher score means a worse outcome | 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
A higher score means a worse outcome | 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
A higher score means a worse outcome | 12 months |
| Gingival Status |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mariella Garcia, DDS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington-The Center for Pediatric Dentistry | Seattle | Washington | 98115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Initial enrollment was performed at the time of dental consent before general anesthesia procedure for all patients. Once the patient enrolled and consented to participate they will be evaluated clinically for remaining inclusion and exclusion criteria during the general anesthesia procedure. 21 patients were not meeting inclusion criteria or met the exclusion criteria so form 97 patients that were enrolled only 76 patients were allocated in the different arms of the study
Recruitment start date was 06/05/2015 and last day was 10/16/2018 . All recruitment took place at the The Center for Pediatric Dentistry
| ID | Title | Description |
|---|---|---|
| FG000 | Nu Smile Zirconia Crown | Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration |
| FG001 | Nu Smile Pre Veneered Crown | Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration |
| FG002 | Composite Strip Crown | Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nu Smile Zirconia Crown | Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration |
| BG001 | Nu Smile Pre Veneered Crown |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fitting | The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
24 months
No reports of adverse events in all three groups
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nu Smile Zirconia Crown | Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration |
Not provided
Not provided
Many families had moved, changed or lost phone services, or were otherwise unable to be reached. There were also a few families who withdrew following treatment due to a disinterest in travelling the distance for follow-up care. The loss of follow up was similar for all treatment groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariella Garcia | University of Washington | 2065431740 | mgarciaf@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2014 | Nov 23, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2015 | Nov 23, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nu Smile Pre Veneered crown | Device | Placement of an anterior primary crown restoration |
|
| Composite strip crown | Device | Placement of an anterior primary crown restoration |
|
The number of teeth scored in the gingival status categories described below
Gingival status 0=Pink, firm, free of inflammation
A higher score means a worse outcome
| 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 | 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
A higher score means a worse outcome | 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 | 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 | 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 | 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 | 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 | 12 months |
Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration
Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration
| BG002 | Composite Strip Crown | Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration |
| BG003 | Total | Total of all reporting groups |
| teeth |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| OG002 | Composite Strip Crown | Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration |
|
|
| Primary | Positioning | Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | Proximal Contact | The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | Marginal Adaptation | The number of teeth scored in the marginal adaptation categories as described below Marginal adaptation 0= No discrepancies detected with explorer
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | Color | The number of teeth scored in the color categories described below Color matching 0= Matches completely or within range of shade and translucency
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | Gingival Status | The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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
A higher score means a worse outcome | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| Primary | 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 | Number of teeth analyzed per group | Posted | Count of Units | Teeth | 12 months | Teeth | Teeth |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Nu Smile Pre Veneered Crown | Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Composite Strip Crown | Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration | 0 | 17 | 0 | 15 | 0 | 17 |
Not provided
Not provided
| Male |
|
| Floss meets significant when passes through contact |
|
|
| Spontaneous and excessive bleeding on probing |
|