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
Phase: NA
Conditions: Primary Dental Caries, Multisurface Origin (Diagnosis)
Sponsor: University of Washington

 
 
 
 
 
 
 
 
 
 
 
 
THE CENTER FOR PEDIATRIC DENTISTRY 
University of Washington 
 
 
 
 
 
 
 
 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator:  
Ana Lucia Seminario 
 
 
 
 
 
Mariella Garcia 
 
Co-Investigators: 
            JoAnna Scott 
 
 
 
 
 
Amy Kim 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
 
1. BACKGROUND, EARLY CHILDHOOD CARIES 
 
Early Childhood Caries (ECC) is a pandemic in the US, particularly within poor minority 
populations where ECC rates are as high as 90%.1 The etiology of this disease is 
thought to include bedtime bottle feeding and vertical transmission of cariogenic bacteria 
(i.e. Strep. Mutans) from mother to child. Mandibular incisors are generally protected 
from the cariogenic bacteria and carbohydrates because of the resting position of the 
tongue over the lingual surfaces of those teeth, leaving maxillary incisors exposed to 
both bacteria and carbohydrates.2 Treatment for ECC is expensive, ranging from $1,000 
or more.  In addition, ECC’s have a large impact on the child’s health like low weight 
gain.3  
 
Historically, stainless steel crowns (SCC) have been the most reliable and predictable in 
longevity. However for the anterior teeth, it is unattractive because of the display of 
metal.  Demand for more esthetic restorations has been on the rise. A procedure was 
presented exploring an open faced crown technique, where the operator cements a 
traditional SSC, opens a window on the facial aspect of the crown to fill and shape the 
tooth colored resin material. This procedure demands more chair time and is also 
technique sensitive.4 By the 1990’s, pre-veneered stainless steel crowns (PVSSC) had 
been on the market with names such as NuSmile crowns, Kinder Krowns and Cheng 
Crowns. NuSmile crowns have shown success by having the strongest veneer facing 
against shear forces, parental acceptance of esthetics, and are less technique 
sensitive.5-7 
 
PVSSC are SSC bonded with thermoplastic composites on the roughened or meshwork 
facial surfaces. It is made from the same SSC used by dentists for many years.  Many 
advantages of these crowns are noted. Parents find the PVSCC’s to be esthetically 
acceptable, hemorrhaging does not affect the resistance or retention, or color of the 
crown, and there is less chair time needed when compared with alternative   
restorations.6 Nevertheless, no system is without disadvantages. The operator is limited 
to crimping only on the lingual surface of the crown because crimping the facial may 
cause the veneer to chip off. This leads to limited adaptability of the crown to the tooth 
surface. In addition, there are only two shades available, making exact colors matching 
very difficult for a single tooth. Overall, the PVSCCs cost more money than SCCs or 
direct resin restorations.8 Recently, NuSmile introduced a new type of anterior crowns, 
the NuSmile ZR. It is made of high grade monolithic zirconia ceramic which provides 
strength, durability and esthetics characteristics to these crowns.   
 
With the variety of options for restoring anterior primary teeth, it is of interest to evaluate 
the long term success of PVSCC, zirconia and composite in terms of durability, esthetics 
and cost effectiveness for the treatment of anterior primary teeth.  
 
 
 
2. PURPOSE 
Notably literature has focused on individual operator experience with the product and 
comparing bonding strengths of the PVSCC’s composite surface, as well as 
autoclavability of PVSSCs8, clinical success with NuSmile crowns9, and their failure 
strengths.10 However, most of the literature mentioned early in dealing with resistance, 
retention and shear forces of the PVCCs are done on bench top or operator experience 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
describing clinical cases. Very few randomized control trials were done on the clinical 
success of PVSCCs and zirconia ceramic crowns.  
The purpose of this pilot study is to evaluate the clinical performance of PVSCC and 
zirconia crowns compared to composite crowns as definitive treatment for multi-surfaced 
affected anterior primary teeth. 
 
3. OBJECTIVES 
The objective of this pilot study is to assess the clinical performance of NuSmile’s Pre-
Veneered Stainless Steel Crown – NuSmile Signature and NuSmile ZR compared with 
composite crowns - Success Essentials esthetic temps/strip crowns - at the Center for 
Pediatric Dentistry, Seattle, Washington. 
 
4. STUDY DESIGN 
This pilot study is a single-center, non-blinded, controlled clinical trial with evaluations at 
baseline; follow up assessments at months 3, 6, 12 and 18; and a final assessment at 
the end of study visit occurring at 24. 
 
5. SAMPLE SIZE 
As this is a pilot study, a sample size of 90 (30 in each arm) subjects will be chosen as a 
convenience sample. This is the number estimated to enroll in a 24 week period. 
 
6. STUDY POPULATION 
Ninety (90) subjects contributing to approximately 120 to 200 crowns on primary teeth 
will be recruited from the patient pool of the Center for Pediatric Dentistry who receive 
care under general anesthesia and enrolled into the study.  A maximum of four crowns 
will be placed in any subject. It is estimated that it will take approximately 24 weeks to 
place all crowns and complete the baseline examination. 
 
6.1 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 
 
6.2 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 
 
 
 
 
 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
7. STUDY PROCEDURES 
 
7.1 Training 
All research study team members will obtain clinical research and HIPAA training prior to 
start of study.  All pediatric dental (PEDO) clinician team who work at the Dental Surgery 
Center (DSC) and are willing to participate in this study will train with the NuSmile 
crowns by preparing extracted or typodont primary teeth and cementing the crowns and 
at least six in vivo cases done under general anesthesia for each crown type in the 
study. Intra and inter-reliability assessment will be obtained (Kappa >0.8). Training and 
calibration will be performed by a representative from NuSmile and Dr. Garcia from the 
Center for Pediatric Dentistry.  
 
7.2 Informed Consent 
All study procedures will be explained to every subject and their parent/guardian, and 
every parent/guardian will provide written consent to participate in this study prior to the 
performance of any study procedures.   
 
7.3 Recruitment and Subject Screening 
All patients at the Center for Pediatric Dentistry that meet the inclusion/exclusion criteria 
will be given the opportunity to participate in this research study. Each subject will be 
screened for compliance with the inclusion/exclusion criteria specified in section 6 prior 
to enrollment in this study. 
 
7.4 Treatment Randomization 
Restorations will be randomly allocated to a patient; all teeth in a single patient will be 
randomly allocated to receive one of the restoration treatments: 1) NuSmile  Signature 
crowns (thirty patients in the intervention group 2) NuSmile ZR crowns (thirty patients in 
the intervention group and 3) and composite strip crowns (thirty patients in control 
group).  
 
The randomization sequence will be created using STATA 12.0 (StataCorp, College 
Station, TX) statistical software using random block sizes, which are known only to the 
study statistician. The randomization list will be created and placed in the order 
determined above into opaque sealed envelopes prior to trial start.  The envelopes will 
be kept in a secure place known only to the study coordinator, research assistants, and 
statistician.   
 
Each patient will be assigned a random treatment when they arrive at the treatment 
appointment and after they have been determined eligible and have signed the consent 
form.  The clinician will be told the treatment assignment immediately prior to the 
treatment appointment.   
 
 
 
7.5 Operative Procedures 
After the subject’s parent/guardian has provided informed consent for participation in the 
study, patient’s sedated procedure will be accomplished. This study will be executed 
within a comprehensive restorative treatment. A rubber dam will be placed and the 
crowns will be placed following manufacturers’ guidelines, see below. 
 
7.5.1 Crown Selection 
The crown size is selected prior to prepping the tooth. The original size of the non-
carious tooth is approximated and the crown size that appears most natural in the child’s 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
mouth will be selected.  For the NuSmile PVSSC Signature crowns, it is recommended 
to choose one to two sizes smaller than the size of a stainless steel crown (SSC) that 
would be deemed if used.  Downsizing compensates for the additional thickness of the 
esthetic facing.  
 
7.5.2 Preparation of the tooth  
A) For NuSmile PVSCC Signature  Crowns: 
The tooth should be prepared to fit the crown so that the crown fits the tooth passively 
without using pressure. The incisal length of the tooth is reduced by approximately 2mm 
with the interproximal contacts opened. A feather-edge margin is created as far 
subgingivally as possible (approximately 1-2mm). The tooth is overall reduced by 
approximately 25-30%. For preparing the tooth subgingivally, and refining the 
preparation, tapered diamond burs may be used, proceeding from coarse to fine as the 
preparation is completed. 
 
B) For NuSmile ZR Crowns: 
The tooth should be prepared to fit the crown so that the crown fits the tooth passively 
without using pressure. The incisal length of the tooth is reduced by approximately 1.5-
2mm with the interproximal contacts opened. With a course tapered bur, the tooth is 
overall reduced supragingivally by approximately 20-25%, or 0.5-1.25mm on all planes 
of the tooth.  Reduction should follow the natural contours of the clinical crown and meet 
in a thin, tapered incisal edge. Carefully extend and refine the preparation margin to a 
feather-edge approximately 1-2mm subgingivally with a thin tapered diamond bur (green 
stripe 6852-012).  Check that no subgingival ledges remain.  Round all line angles and 
point angles of prepared teeth.     
 
C) For Strip Composite Crowns:  
The celluloid crown is selected based on the mesiodistal width of the tooth. The incisal 
length of the tooth is reduced by approximately 2mm with the interproximal contacts 
opened. A feather-edge margin is created supra or at gingival level. The tooth is overall 
reduced by approximately 15-20%. For preparing the tooth, and refining the preparation, 
tapered diamond or tungsten carbide burs may be used.  
 
 
7.5.3 Crown Fitting, Adjustment and Cementation 
A) For NuSmile PVSCC Signature Crowns: 
In some cases, shortening the crown from the gingival margin may be necessary to 
achieve the desired results. The NuSmile Shortening Bur may be used at low range 
speed with a water spray to circumferentially reduce and feather the crown margins. 
After shortening, the composite polisher may be used to restore a polished surface to 
the esthetic facing.  
 
A properly fitted crown will have a passive fit and be seated with finger pressure only. A 
“snap fit” is both undesirable and counter-productive as it may result in failure of the 
veneer. If the crown does not fit passively, the preparation must be refined to fit the 
crown.  Crimping is not necessary, but if needed, excessive crimping or crimping near 
the facing must be avoided.  
 
Clean the teeth of saliva, blood or debris and control gingival hemorrhage.  NuSmile’s 
Bio-active Resin Modified Glass Ionomer Cement will be used to cement the crowns 
according to the manufacturer’s directions for use. 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
 
Once seated and after allowing enough time for the cement to set, a white stone or 
composite finishing bur may be used to equilibrate the veneer out of excessive occlusal 
contact in centric and excursion functions. The opposing teeth may be slightly adjusted, 
if needed. 
 
It may be desirable to trim the veneer flush with the incisal edge if the patient 
demonstrates bruxism patterns or end-on occlusion. The distal point angle may be 
rounded to shape the crown for a right or left anterior. 
 
B) For NuSmile ZR crowns: 
 
Use NuSmile Try-In Crowns to test the fit and to avoid contamination with saliva or blood 
of NuSmile ZR Crown’s prepared internal surface.  If contamination with saliva or blood 
occurs, clean the internal surface of the NuSmile ZR Crown with Ivoclean or sandblast 
with aluminum oxide.   
 
A properly fitted crown will have a passive fit and be seated with finger pressure only. A 
“snap fit” is both undesirable and counter-productive as it may result in fracture of the 
crown. If the crown does not fit passively, the preparation must be refined to fit the 
crown.  
 
NuSmile ZR Crowns should only be adjusted with burs specifically designed for 
adjusting zirconia restorations taking care to use a light touch and a copious water 
spray. The NuSmile ZR Adjustment Burs can be used to circumferentially reduce and 
feather the crown margins when shortening a crown is necessary. The crown walls are 
very thin and should not be adjusted any more than 0.5mm in the incisal ½ of the 
proximal area as necessary. No other areas of the crowns should be adjusted. If 
adjustments are made, the ZR polishers should be used to restore a smooth surface to 
the crown. 
 
Clean the teeth of saliva, blood or debris and control gingival hemorrhage.  NuSmile’s 
Bio-active Resin Modified Glass Ionomer Cement will be used to cement the crowns 
according to the manufacturer’s directions for use. 
 
C) For Strip Composite Crowns:  
Trim the crown form and pierce one hole in the palatal incisal angle with a high-speed 
bur. Etch the enamel for approximately 20 seconds, wash and dry without desiccation of 
the dental structures. Apply a thin layer of bonding resin cure for 20 seconds ensuring 
that all surfaces are bonded equally.  Fill celluloid crown with the appropriate shade of 
composite and seat with gentle, even, pressure, allowing excess to exit freely. Light-cure 
each tooth surface (labially, incisally and palatally) equally. Remove celluloid crown 
gently and adjust form and finish with either composite finishing burs or abrasive discs.   
 
 
 
7.5.4 Failure to Fit 
Teeth randomized for treatment will be included in the study even if they cannot 
accommodate the crown and therefore a composite crown is placed instead (intention-
to-treat principle). The investigator will keep record of the teeth for further adjustment in 
the analysis. The reason for the fitting failure will also be recorded (See Appendix 2). If 
the tooth needs to be extracted (not matching inclusion/exclusion criteria), it will be 
excluded from the trial. 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
 
 
 
8. CLINICAL ASSESSMENTS 
Clinical Assessments for both groups will be done at post crown placement (baseline); 
and months 3, 6, 12, and 18; and end of study visit occurring in range of 24 to 30 months 
from baseline. Please see Appendix 3 for scoring Criteria for the following: 
• Fit 
• Positioning 
• Proximal Contact 
• Marginal Adaptation 
• Color: Match, staining/color change 
• Gingival Status 
• Retention of the crown 
• Integrity of the veneer/composite 
• Secondary Caries 
• History of trauma 
• Clinical pulp pathology 
• Radiographical pulp pathology 
• Parents’ esthetic satisfaction 
 
 
9. HUMAN SUBJECTS PROTECTION 
Adverse Events (AE) will be documented as to onset, severity, duration, remedy, and 
relatedness to the test device and will be recorded on source documents and on case 
report forms. Any study staff member becoming aware of an AE must bring it to the 
attention of the Principal Investigator as soon as possible, and the Principal Investigator 
is responsible for reporting the Adverse Event, as needed, to the appropriate agencies 
and the study sponsor.  AE reporting will follow the Western Institutional Review Board 
(WIRB) guidelines as below. 
 
Adverse Events (AE) are any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with the subject’s participation in 
the research, whether or not considered related to the subject’s participation in the 
research. Report to WIRB only AE that in the opinion of the investigator may represent 
unanticipated problems involving risks to the other subjects in the research, as 
defined: 
• 
Event is Unexpected (in terms of nature, severity, or frequency) given (a) the 
research procedures that are described in the protocol-related documents, such 
as the IRB-approved research protocol and informed consent document, or the 
Investigator Brochure; and (b) the characteristics of the subject population being 
studied,  
• 
Related or possibly related to participation in the research (possibly related 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.  
 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
If the adverse event is clearly not related to the study drug, device, procedures, or 
washout process, it would not represent a risk to other subjects in the research or a 
“problem” for the study and, therefore, does not have to be reported to WIRB.   
 
 
10. STUDY ASSESSMENTS 
Clinical Assessments will be done at baseline post crown placement; at months 3, 6, 12 
and 18; and end of study visit occurring in range of 24 to 30 months from baseline.  
 
Assessments and documentation required at each assessment interval: 
• Photographs of selected teeth  
  
 
 
Baseline 
• Photographs of tooth preparations   
 
 
Baseline and when possible 
• Photographs of cemented crowns   
 
 
Baseline 
• Photographs of occlusal and frontal views  
Baseline and when possible 
• Assessment of fit  
 
 
 
 
 
All intervals 
• Assessment of positioning   
 
 
 
All intervals 
• Assessment of proximal contact  
 
 
 
All intervals 
• Assessment of marginal adaptation  
 
 
All intervals 
• Assessment of color: match , staining/color change 
All intervals 
• Assessment of time placement 
 
 
 
Baseline 
• Assessment of gingival status 
All intervals  
• Assessment of retention 
 
 
 
 
3, 6, 12, 18 and 24 mo 
• Assessment of veneer/composite integrity  
 
3, 6, 12, 18 and 24 mo 
• Assessment of secondary caries 
 
 
 
3, 6, 12, 18 and 24 mo 
• Assessment of trauma 
 
 
 
 
3, 6, 12, 18 and 24 mo 
• Assessment of clinical pulp pathology 
 
 
3, 6, 12, 18 and 24 mo 
• Assessment of radiographic pulp pathology 
 
24 mo 
• Assessment of tooth  
 
 
 
 
All intervals 
• Assessment of parents’ esthetic satisfaction 
All intervals (baseline at 3-
month follow up)  
 
Non-recall assessment to be done at the time of tooth/crown lost to study due to trauma. 
If this was to occur, the patient would be discontinued from study and the justification 
recorded. 
 
 
 
 
11.0 DATA ANALYSIS 
Descriptive statistics (means, standard deviations, counts, and percentages) will be 
calculated for all variables.  To evaluate if the primary efficacy variables differ by the 
three treatment groups (NuSmile PVSCC Signature Crowns, NuSmile ZR, and Strip 
composite crowns), ANOVA or Chi-square tests of association will be performed. 
 
All subjects evaluated at the 6-month interval or beyond and subjects who have lost 
crowns or teeth will be considered for efficacy. All enrolled subjects defined here as 
those who have had at least one crown placed will be evaluated for safety. Any missing, 
unused or false data will be omitted from data analysis. 
 
The primary efficacy variables in this trial are fit, positioning, proximal contact, marginal 
adaptation, color match, gingival status, crown retention, veneer/composite integrity, 
secondary caries, occlusal integrity, history of trauma, clinical pulp pathology, parents’ 
esthetic satisfaction.  Scores for efficacy variables will be summarized and displayed 
using descriptive statistics (means, standard deviations, counts, and percentages). 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
Inferential statistics will be used to detect significant differences in the primary efficacy 
variables by the treatment status at baseline and at 6, 12, 18, and 24 month follow-up. 
Statistical differences will be calculated using logistic regression models accounting for 
within cluster variance using generalized estimating equations (GEE).   
  
Safety variables include Adverse Events and Unanticipated Adverse Device Effects. All 
subjects that have had crowns placed will be evaluated for safety. Descriptions of 
occurrences, incidence, severity and required treatments for 
Adverse Events and Unanticipated Adverse Device Effects Will be summarized and 
tabulated where appropriate. 
 
 
 
 
12.0 STUDY TERMINATION/SUBJECT WITHDRAWAL 
 
 
12.1 Study Termination 
This study may be terminated for the following reasons: 
• Discovery of unforeseen risk that could jeopardize the dental/physical well-being of 
subjects 
• Enrollment or recall rates those are not likely to produce sufficient data for evaluation of 
safety and efficacy 
• Non-compliance with the study protocol, the Investigator Agreement, applicable FDA 
regulations or conditions of approval imposed by the reviewing IRB 
• Withdrawal of IRB approval 
In the event of study termination, the Principal Investigator will determine whether 
subjects are in need of additional treatment and/or follow-up observation as a result of 
participation in this trial. 
 
 
 
12.2 Subject Withdrawal 
Subjects may be withdrawn from this study for the following reasons. 
• Concurrent illness 
• Unanticipated Adverse Device Effect 
• Unwillingness to further participate 
The Principal lnvestigator will determine whether withdrawn subjects are in need of 
additional treatment and/or follow-up observation as a result of participation in this trial. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
 
 
REFERENCES 
 
1) Edelstein BL, Douglass CW:Dispelling the myth that 50% of U.S. schoolchildren have 
never had a cavity. Public Health Rep. 1995 Sep-Oct;110(5):522-30; discussion 521, 
531-3 
 
2) Tinanoff N., O’Sullivan DM. Early Childhood caries: Overview and recent findings. 
Pediatr Dent 1997; 19: 12-6. 
 
3) Jones DB, Schlife CM,Phipps KR: An oral health survey of HeadStart children in 
Alaska: oral health status, treat- ment needs, and cost of treatment. J Public Health 
Dent. 1992 52:86-93, 1992. 
 
4) Croll TP: Primary Incisor Restoration Using Resin-veneered Stainless Steel Crowns. 
ASDC J Dent Child. 1998 Mar-Apr;65(2):89-95. 
 
5) Lee Y-K, Lu H, Powers JM. Fracture Resistance and Fracture Patterns of Anterior 
Esthetic Pediatric Crowns Loaded at End-to End Inter-Incisal Angle. Houston 4) Acs G, 
Lodolini G, Kaminsky S, Cisneros GJ: Effect of nursing caries on body weight in a 
pediatric population. Pediatr Dent. 1992 14:302-5. 
 
6) Champagne C, Waggoner W, Ditmyer M, Casamassimo PS: Parental Satisfaction 
with Preveneered Stainless Steel Crowns for Primary Anterior Teeth. Pediatr Dent. 2007 
29:6, 465-9. 
 
7) Oueis H, Atwan S, Pajtas B, Casamassimo P. Use of Pre-Veneered Stainless Steel 
Crowns by Pediatric Dentists. Pediatr Dent. 2010 Sep-Oct;32(5):413-6. 
 
8) Wickersham GT, Seale SN, Frysh H: Color change and fracture resistance of two 
preveneered stainless-steel crowns after sterilization. Pediatr Dent. 1995 Jan-
Feb;17(1):36-40. 
 
9) MacLean JK, Champagne CE, Waggoner WF, Ditmyer MM, Casamassimo P: Clinical 
Outcomes for Primary Anterior Teeth Treated with Preveneered Stainless Steel Crowns. 
Pediatr Dent. 2007 29:377-81. 
 
10) Waggoner W, Howard C: Failure strength of four veneered primary stainless steel 
crowns. Pediatr Dent. 1995 Jan-Feb;17(1):36-40. 
 
 
 
 
 
 
 
 
 
 
 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
 
 
APPENDIX 1: FITTING 
 
FITTING 
A= 
Good natural retention  
B= 
Moderate natural retention  
C= 
Little or no natural retention 
 
APPENDIX 2: POSITIONING  
 
POSITIONING 
A= 
Proper position  
B= 
Rotated – in occlusion  
C= 
Not in occlusion with or without rotation 
 
APPENDIX 3: PROXIMAL CONTACT  
 
PROXIMAL CONTACT 
A= 
Open spaces    
B= 
Floss meets  little or no resistance when passes through contact   
C= 
Floss meets  significant when passes through contact   
 
 
 
 
APPENDIX 4: MARGINAL ADAPTATION  
 
MARGINAL ADAPTATION 
A= 
No discrepancies detected with explorer  
B= 
Detectable discrepancies but clinically acceptable 
C= 
Detectable discrepancies, not acceptable –replacement required 
 
 
 
 
APPENDIX 5: COLOR: MATCH, STAINING/COLOR CHANGE 
 
COLOR: MATCH, STAINING/COLOR CHANGE 
A= 
Matches structure 
B= 
Does not completely match but within range of shade and translucency 
C1= Outside range with yellow to yellow/brown discoloration 
C2= Outside range with light gray to dark gray discoloration 
C3= Outside range for reason other than yellowing or graying  
 
 
APPENDIX 6: TIME PLACEMENT  
 
TIME PLACEMENT 
A= 
≤ 30 min 
B= 
>30 - ≤ 45 min 
C= 
> 45 min 
 
 
 
 
APPENDIX 7: GINGIVAL STATUS 
 
 
  

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
GINGIVAL STATUS 
A= 
Pink, firm, free of inflammation 
B= 
Red and/or inflamed – no bleeding on probing 
C= 
Red – bleeding on probing 
D= 
Spontaneous and excessive bleeding on probing 
 
 
APPENDIX 8: RETENTION  
 
 
 
RETENTION 
 
A= 
Intact 
B= 
Partially missing 
C1= Missing – no cement remaining on tooth or crown 
C2= Missing – some or all cement remaining on tooth 
C3= Missing – some or all cement remaining on crown interior ( if crown available) 
C4= Missing – some cement remaining on both tooth and crown interior ( if crown 
available) 
 
 
 
APPENDIX 9: VENEER/COMPOSITE INTEGRITY  
 
 
VENEER/COMPOSITE INTEGRITY 
 
 
A= 
Intact 
B1= Partially missing – one third missing 
B2= Partially missing – two thirds missing 
B3= Partially missing – more than two thirds missing 
C4= All veneer/composite missing 
 
APPENDIX 10: SECONDARY CARIES 
 
 
SECONDARY CARIES 
A= 
Absent 
B= 
Present 
 
 
 
APPENDIX 11: TRAUMA 
 
 
TRAUMA 
A= 
Absent 
B= 
Present 
 
 
 
 
 
APPENDIX 12: CLINICAL PULP PATHOLOGY 
 
CLINICAL PULP PATHOLOGY 
A= 
Absent 
B= 
Present 
 
 
 
 
APPENDIX 13: RADIOGRAPHIC PULP PATHOLOGY 
 
 
RADIOGRAPHIC PULP PATHOLOGY 

 
The Center for Pediatric Dentistry, University of Washington – 11/20/2014 
 
A= 
Absent 
B= 
Present 
 
 
 
APPENDIX 14: PARENTS’ ESTHETIC SATISFACTION 
 
 
1. Which of the following best describes your thoughts overall about the 
appearance of your child’s teeth? 
a. Very satisfied 
b. Somewhat satisfied 
c. Somewhat dissatisfied 
d. Very dissatisfied 
 
2. If not “very satisfied”, which of the following are you concerned about? (circle 
“yes” or “no” for each subcategory) 
a. Shape  
 
 
 
 
 
 
1. Yes  
2. No 
b. Color 
 
 
 
 
 
 
1. Yes  
2. No 
c. Alignment  
 
 
 
 
 
1. Yes  
2. No 
d. Spacing between teeth   
 
 
 
1. Yes  
2. No 
e. Crowding of teeth  
 
 
 
 
1. Yes  
2. No 
f. Speckled/spotted/streaky/irregular/blotchy appearance 1. Yes  
2. No 
g. Other: _______________________________________________________