Trial Outcomes & Findings for Clinical Trial NuSmile Crowns (NCT NCT04975321)

NCT ID: NCT04975321

Last Updated: 2022-05-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-05-09

Participant Flow

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

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

Unit of analysis: teeth

Participant milestones

Measure	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	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	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
Overall Study STARTED	25 70	26 80	25 70
Overall Study COMPLETED	15 40	15 47	17 48
Overall Study NOT COMPLETED	10 30	11 33	8 22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Nu Smile Zirconia Crown n=40 teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 teeth 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	Composite Strip Crown n=48 teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration	Total n=135 teeth Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	15 Participants n=15 Participants	17 Participants n=17 Participants	47 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=17 Participants	0 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=17 Participants	0 Participants n=47 Participants
Age, Continuous	3.4 years STANDARD_DEVIATION 0.8 • n=15 Participants	3.4 years STANDARD_DEVIATION 0.8 • n=15 Participants	3.4 years STANDARD_DEVIATION 0.8 • n=17 Participants	3.4 years STANDARD_DEVIATION 0.8 • n=47 Participants
Sex: Female, Male Female	6 Participants n=15 Participants	11 Participants n=15 Participants	9 Participants n=17 Participants	26 Participants n=47 Participants
Sex: Female, Male Male	9 Participants n=15 Participants	4 Participants n=15 Participants	8 Participants n=17 Participants	21 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 participants n=15 Participants	15 participants n=15 Participants	17 participants n=17 Participants	76 participants n=47 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Fitting 0= Good retention	37 Teeth	42 Teeth	48 Teeth
Fitting 1=Moderate natural retention	3 Teeth	5 Teeth	0 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Positioning Proper position	40 Teeth	45 Teeth	46 Teeth
Positioning Rotated- in occlusion	0 Teeth	2 Teeth	2 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Proximal Contact Floss meets significant when passes through contact	1 Teeth	0 Teeth	0 Teeth
Proximal Contact Open spaces	30 Teeth	41 Teeth	44 Teeth
Proximal Contact Floss meets little or no resistance when passes through contact	9 Teeth	6 Teeth	4 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Marginal Adaptation No discrepancies detected with explorer	40 Teeth	47 Teeth	43 Teeth
Marginal Adaptation Detectable discrepancies but clinically acceptable	0 Teeth	0 Teeth	5 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Color Matches completely or within range of shade and translucency	40 Teeth	47 Teeth	48 Teeth
Color Outside range for yellow, yellow/brown discoloration or gray discoloration	0 Teeth	0 Teeth	0 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Gingival Status Pink, firm, free of inflammation	9 Teeth	5 Teeth	0 Teeth
Gingival Status Red and/or inflamed - no bleeding on probing	8 Teeth	18 Teeth	14 Teeth
Gingival Status Spontaneous and excessive bleeding on probing	23 Teeth	24 Teeth	34 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Retention of the Crown Intact	40 Teeth	47 Teeth	48 Teeth
Retention of the Crown Partially missing	0 Teeth	0 Teeth	0 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Integrity of the Veneer/Composite Intact	40 Teeth	47 Teeth	47 Teeth
Integrity of the Veneer/Composite Partially missing - one third missing	0 Teeth	0 Teeth	1 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Secondary Caries Absent	39 Teeth	43 Teeth	42 Teeth
Secondary Caries Present	1 Teeth	4 Teeth	6 Teeth

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
History of Trauma Absent	39 Teeth	38 Teeth	47 Teeth
History of Trauma Present	1 Teeth	9 Teeth	1 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Clinical Pulp Pathology Absent	39 Teeth	47 Teeth	47 Teeth
Clinical Pulp Pathology Present	1 Teeth	0 Teeth	1 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Radiographical Pulp Pathology Absent	37 Teeth	43 Teeth	48 Teeth
Radiographical Pulp Pathology Present	3 Teeth	4 Teeth	0 Teeth

PRIMARY outcome

Timeframe: 12 months

Population: Number of teeth analyzed per group

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

Outcome measures

Measure	Nu Smile Zirconia Crown n=40 Teeth Anterior primary teeth which received a NuSmile zirconia crown as a final restoration Nu Smile Zirconia crown: Placement of an anterior primary crown restoration	Nu Smile Pre Veneered Crown n=47 Teeth 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	Composite Strip Crown n=48 Teeth Anterior primary teeth which received a composite strip crown as a final restoration Composite strip crown: Placement of an anterior primary crown restoration
Parent's Esthetic Satisfaction Satisfied	38 Teeth	47 Teeth	48 Teeth
Parent's Esthetic Satisfaction Dissatisfied	2 Teeth	0 Teeth	0 Teeth

Adverse Events

Nu Smile Zirconia Crown

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nu Smile Pre Veneered Crown

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Composite Strip Crown

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mariella Garcia

University of Washington

Phone: 2065431740

Email: mgarciaf@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place