Primary Dental Caries, Multisurface Origin (Diagnosis)
Conditions
Keywords
Anterior primary teeth restorations
Brief summary
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.
Interventions
DEVICENu Smile Zirconia crown
Placement of an anterior primary crown restoration
DEVICENu Smile Pre Veneered crown
Placement of an anterior primary crown restoration
DEVICEComposite strip crown
Placement of an anterior primary crown restoration
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fitting | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 40 |
| 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 | 15 |
| 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 | 47 |
| 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 | 17 |
| 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 | 48 |
| Total | 182 |
Baseline characteristics
| Characteristic | Nu Smile Pre Veneered Crown | Composite Strip Crown | Nu Smile Zirconia Crown | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 17 Participants | 15 Participants | 47 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.4 years STANDARD_DEVIATION 0.8 | 3.4 years STANDARD_DEVIATION 0.8 | 3.4 years STANDARD_DEVIATION 0.8 | 3.4 years STANDARD_DEVIATION 0.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 15 participants | 17 participants | 15 participants | 76 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 6 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Clinical Pulp Pathology | Absent | 39 Teeth |
| Nu Smile Zirconia Crown | Clinical Pulp Pathology | Present | 1 Teeth |
| Nu Smile Pre Veneered Crown | Clinical Pulp Pathology | Absent | 47 Teeth |
| Nu Smile Pre Veneered Crown | Clinical Pulp Pathology | Present | 0 Teeth |
| Composite Strip Crown | Clinical Pulp Pathology | Absent | 47 Teeth |
| Composite Strip Crown | Clinical Pulp Pathology | Present | 1 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 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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Color | Matches completely or within range of shade and translucency | 40 Teeth |
| Nu Smile Zirconia Crown | Color | Outside range for yellow, yellow/brown discoloration or gray discoloration | 0 Teeth |
| Nu Smile Pre Veneered Crown | Color | Matches completely or within range of shade and translucency | 47 Teeth |
| Nu Smile Pre Veneered Crown | Color | Outside range for yellow, yellow/brown discoloration or gray discoloration | 0 Teeth |
| Composite Strip Crown | Color | Matches completely or within range of shade and translucency | 48 Teeth |
| Composite Strip Crown | Color | Outside range for yellow, yellow/brown discoloration or gray discoloration | 0 Teeth |
Primary
Fitting
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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Fitting | 0= Good retention | 37 Teeth |
| Nu Smile Zirconia Crown | Fitting | 1=Moderate natural retention | 3 Teeth |
| Nu Smile Pre Veneered Crown | Fitting | 0= Good retention | 42 Teeth |
| Nu Smile Pre Veneered Crown | Fitting | 1=Moderate natural retention | 5 Teeth |
| Composite Strip Crown | Fitting | 0= Good retention | 48 Teeth |
| Composite Strip Crown | Fitting | 1=Moderate natural retention | 0 Teeth |
Primary
Gingival Status
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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Gingival Status | Red and/or inflamed - no bleeding on probing | 8 Teeth |
| Nu Smile Zirconia Crown | Gingival Status | Pink, firm, free of inflammation | 9 Teeth |
| Nu Smile Zirconia Crown | Gingival Status | Spontaneous and excessive bleeding on probing | 23 Teeth |
| Nu Smile Pre Veneered Crown | Gingival Status | Red and/or inflamed - no bleeding on probing | 18 Teeth |
| Nu Smile Pre Veneered Crown | Gingival Status | Pink, firm, free of inflammation | 5 Teeth |
| Nu Smile Pre Veneered Crown | Gingival Status | Spontaneous and excessive bleeding on probing | 24 Teeth |
| Composite Strip Crown | Gingival Status | Pink, firm, free of inflammation | 0 Teeth |
| Composite Strip Crown | Gingival Status | Spontaneous and excessive bleeding on probing | 34 Teeth |
| Composite Strip Crown | Gingival Status | Red and/or inflamed - no bleeding on probing | 14 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
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | History of Trauma | Absent | 39 Teeth |
| Nu Smile Zirconia Crown | History of Trauma | Present | 1 Teeth |
| Nu Smile Pre Veneered Crown | History of Trauma | Absent | 38 Teeth |
| Nu Smile Pre Veneered Crown | History of Trauma | Present | 9 Teeth |
| Composite Strip Crown | History of Trauma | Absent | 47 Teeth |
| Composite Strip Crown | History of Trauma | Present | 1 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 1. Partially missing - one third missing 2. Completely missing A higher score means a worse outcome
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Integrity of the Veneer/Composite | Intact | 40 Teeth |
| Nu Smile Zirconia Crown | Integrity of the Veneer/Composite | Partially missing - one third missing | 0 Teeth |
| Nu Smile Pre Veneered Crown | Integrity of the Veneer/Composite | Intact | 47 Teeth |
| Nu Smile Pre Veneered Crown | Integrity of the Veneer/Composite | Partially missing - one third missing | 0 Teeth |
| Composite Strip Crown | Integrity of the Veneer/Composite | Intact | 47 Teeth |
| Composite Strip Crown | Integrity of the Veneer/Composite | Partially missing - one third missing | 1 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 1. Detectable discrepancies but clinically acceptable 2. Detectable discrepancies, not acceptable -replacement required A higher score means a worse outcome
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Marginal Adaptation | No discrepancies detected with explorer | 40 Teeth |
| Nu Smile Zirconia Crown | Marginal Adaptation | Detectable discrepancies but clinically acceptable | 0 Teeth |
| Nu Smile Pre Veneered Crown | Marginal Adaptation | No discrepancies detected with explorer | 47 Teeth |
| Nu Smile Pre Veneered Crown | Marginal Adaptation | Detectable discrepancies but clinically acceptable | 0 Teeth |
| Composite Strip Crown | Marginal Adaptation | No discrepancies detected with explorer | 43 Teeth |
| Composite Strip Crown | Marginal Adaptation | Detectable discrepancies but clinically acceptable | 5 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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Parent's Esthetic Satisfaction | Satisfied | 38 Teeth |
| Nu Smile Zirconia Crown | Parent's Esthetic Satisfaction | Dissatisfied | 2 Teeth |
| Nu Smile Pre Veneered Crown | Parent's Esthetic Satisfaction | Satisfied | 47 Teeth |
| Nu Smile Pre Veneered Crown | Parent's Esthetic Satisfaction | Dissatisfied | 0 Teeth |
| Composite Strip Crown | Parent's Esthetic Satisfaction | Satisfied | 48 Teeth |
| Composite Strip Crown | Parent's Esthetic Satisfaction | Dissatisfied | 0 Teeth |
Primary
Positioning
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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Positioning | Proper position | 40 Teeth |
| Nu Smile Zirconia Crown | Positioning | Rotated- in occlusion | 0 Teeth |
| Nu Smile Pre Veneered Crown | Positioning | Proper position | 45 Teeth |
| Nu Smile Pre Veneered Crown | Positioning | Rotated- in occlusion | 2 Teeth |
| Composite Strip Crown | Positioning | Proper position | 46 Teeth |
| Composite Strip Crown | Positioning | Rotated- in occlusion | 2 Teeth |
Primary
Proximal Contact
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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Proximal Contact | Floss meets little or no resistance when passes through contact | 9 Teeth |
| Nu Smile Zirconia Crown | Proximal Contact | Floss meets significant when passes through contact | 1 Teeth |
| Nu Smile Zirconia Crown | Proximal Contact | Open spaces | 30 Teeth |
| Nu Smile Pre Veneered Crown | Proximal Contact | Open spaces | 41 Teeth |
| Nu Smile Pre Veneered Crown | Proximal Contact | Floss meets little or no resistance when passes through contact | 6 Teeth |
| Nu Smile Pre Veneered Crown | Proximal Contact | Floss meets significant when passes through contact | 0 Teeth |
| Composite Strip Crown | Proximal Contact | Open spaces | 44 Teeth |
| Composite Strip Crown | Proximal Contact | Floss meets significant when passes through contact | 0 Teeth |
| Composite Strip Crown | Proximal Contact | Floss meets little or no resistance when passes through contact | 4 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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Radiographical Pulp Pathology | Absent | 37 Teeth |
| Nu Smile Zirconia Crown | Radiographical Pulp Pathology | Present | 3 Teeth |
| Nu Smile Pre Veneered Crown | Radiographical Pulp Pathology | Absent | 43 Teeth |
| Nu Smile Pre Veneered Crown | Radiographical Pulp Pathology | Present | 4 Teeth |
| Composite Strip Crown | Radiographical Pulp Pathology | Absent | 48 Teeth |
| Composite Strip Crown | Radiographical Pulp Pathology | Present | 0 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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Retention of the Crown | Intact | 40 Teeth |
| Nu Smile Zirconia Crown | Retention of the Crown | Partially missing | 0 Teeth |
| Nu Smile Pre Veneered Crown | Retention of the Crown | Intact | 47 Teeth |
| Nu Smile Pre Veneered Crown | Retention of the Crown | Partially missing | 0 Teeth |
| Composite Strip Crown | Retention of the Crown | Intact | 48 Teeth |
| Composite Strip Crown | Retention of the Crown | Partially missing | 0 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
Time frame: 12 months
Population: Number of teeth analyzed per group
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Nu Smile Zirconia Crown | Secondary Caries | Absent | 39 Teeth |
| Nu Smile Zirconia Crown | Secondary Caries | Present | 1 Teeth |
| Nu Smile Pre Veneered Crown | Secondary Caries | Absent | 43 Teeth |
| Nu Smile Pre Veneered Crown | Secondary Caries | Present | 4 Teeth |
| Composite Strip Crown | Secondary Caries | Absent | 42 Teeth |
| Composite Strip Crown | Secondary Caries | Present | 6 Teeth |