Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
Phase: NA
Conditions: Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
Sponsor: University of Michigan

 
 
 
 
 
 
 
 
Official Title: Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) 
Dental Crown Study 
 
NCT Number: NCT03036579 
 
Document Date: May 19, 2022  

  
 
 
 
Clinical Evaluation of Chairside CAD/CAM 
Zirconia-reinforced Lithium Silicate Ceramic 
Crowns 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Copyright University of Michigan 2015: This Clinical Investigation Proposal, or any part thereof, may neither be 
passed on to third parties nor may it be reproduced, stored in a retrieval system, or transmitted, in any form or by 
any means; electronic, mechanical, photocopying, recording, or otherwise, without prior permission of Dr. Dennis J. 
Fasbinder, University of Michigan, USA. 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
19 May 2022  
PI: Dr DJ Fasbinder 
 
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1 Investigation Title 
Clinical Evaluation of Chairside CAD/CAM Zirconia-reinforced Lithium Silicate Ceramic 
Crowns 
 
2 Investigators 
Dennis J. Fasbinder, DDS 
Clinical Professor 
 
Gisele Neiva, DDS, MS 
Clinical Associate Professor 
 
Donald Heys, DDS, MS 
Professor of Dentistry 
 
Ronald Heys, DDS, MS 
Professor of Dentistry 
 
Joseph B. Dennison, DDS, MS, MS 
Emeritus Professor of Dentistry 
 
Department of Cariology, Restorative Sciences, and Endodontics 
School of Dentistry 
University of Michigan 
1011 N. University 
Ann Arbor, Michigan  48109-1078  U.S.A. 
Phone: (734) 647-4450 
Fax: (734) 936-1597 
e-mail: Dr. Fasbinder  djfas@umich.edu 
  
 
 
3 Sponsor 
 
Dentsply/Caulk 
38 West Clarke Ave. 
Milford, DE 19963 
Phone: (800) 532-2855 
Fax: (302) 422-3591 
 
Monitor: Dr. Sridhar Janyavula, BDS, MS; Clinical Research Dentist 
(302) 430-7337 
 
4 Background 
 
 
There has been significant interest in computer assisted design/computer assisted 
machining (CAD/CAM)-generated restorations as the technology has evolved.  Of particular 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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PI: Dr DJ Fasbinder 
 
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interest are newer high strength materials for crowns and onlays.  Popular ceramic materials with 
high strength are primarily limited to fabrication by a dental laboratory that requires at least two 
dental appointments for completion of the restoration.  A recently introduced zirconia-reinforced 
lithium silicate material is designed to provide a high strength alternative to laboratory fabricated 
high strength ceramics for crowns and onlays. 
 
 
This new glass ceramic material is three times stronger than currently marketed ceramic 
materials for CAD/CAM chair-side applications and equal in strength to the only other high 
strength ceramic material available for chairside CAD/CAM restorations, that being lithium 
disilicate (emaxCAD by Ivoclar).  Celtra Duo is provided in a precrystallized block form 
allowing for the option of either polishing the crown after it is milled or oven-firing it depending 
on the specific needs of the clinical case.  This is a potential clinical advantage in that the post-
milling processing is simpler and more streamlined compared to the lithium disilicate high 
strength material resulting in a more efficient delivery process for the patient.  The chair-side 
process using the CEREC 3D system also avoids the final impression process, temporization 
process, and second dental appointment generally required to complete high strength all-ceramic 
crowns from a dental laboratory.   
 
 
It is the intent of this investigation to evaluate the clinical application and performance of 
the new high strength zirconia-reinforced lithium disilicate material (Celtra Duo by Dentsply) for 
CAD/CAM-generated chair-side restorations in single crown applications.     
 
5 Summary of Objectives and Design 
 
 
This investigation will be a prospective, longitudinal clinical trial to study the clinical 
performance of a recently introduced zirconia-reinforced, lithium silicate material (Celtra Duo by 
Dentsply) for CAD/CAM generated restorations.  Celtra Duo crowns will be evaluated for a 
period of five years.   
 
6 Specific Aims 
The specific aims of this project are: 
1. Evaluate the short-term post-operative sensitivity associated with the adhesive luting 
technique of crowns using a self-etch universal adhesive and a dual-cured resin cement. 
2. Evaluate the longitudinal clinical performance of both polished and oven-fired zirconia-
reinforced lithium silicate crowns 
3.  Evaluate the longitudinal clinical performance of zirconia-reinforced lithium silicate 
crowns over five years of clinical service.  The crowns will be evaluated with modified 
USPHS criteria for margin discoloration, margin finish, margin adaptation, proximal 
contact, wear of opposing cusps, anatomical form, surface finish, and recurrent caries. 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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PI: Dr DJ Fasbinder 
 
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7 Research Plan: Methods and Materials 
 
7.1 Subjects 
 
 
The patient population will be selected from current patients under clinical treatment at 
the University of Michigan Dental Clinics.  Patients will be over 18 years of age, of either 
gender, and of any ethnic background.  Each patient should have at least one carious lesion or 
defective restoration to be restored on a maxillary or mandibular bicuspid or molar. Each lesion 
or defective restoration should exhibit sufficient size to extend more than one-half the intercuspal 
width of the tooth requiring a full crown restoration.  All teeth will test vital and be 
asymptomatic at the beginning of treatment.  No more than two restorations will be placed per 
patient.  If a patient presents with more than two acceptable teeth for the study, molar teeth will 
be included prior to bicuspid teeth.  Exclusion criteria will include: 
 
Devital or sensitive teeth 
 
Teeth with prior endodontic treatment of any kind 
 
Teeth with a history of direct or indirect pulp capping procedures 
 
Patients with significant untreated dental disease to include periodontitis and rampant caries 
 
Pregnant or lactating women 
 
Patients with a history of allergies to any of the materials to be used in the study 
 
Patients unable to return for the recall appointments 
 
 
7.2 Informed Consent 
 
 
The Medical Institutional Review Board of the University of Michigan must review and 
approve the investigation protocol.  Patients can be recruited to the study as soon as the contract 
is completed and funding is provided.  Patients who are eligible for the study will be screened by 
the Investigators and Clinical Research Coordinator and fully informed of the nature of the study 
and the need for long-term availability.  Each patient who participates in the study will sign an 
informed consent agreement and the originals will remain at the University.  Patients will be 
charged $350 for each restoration.  As an incentive for patients to be available for the recall 
intervals, patients will receive $50 for every yearly recall that they return to be examined.  
Patients will also receive free bitewing radiographs at the three-year recall appointment. 
 
After admission to the study a subject may withdraw at any time for any reason. The right 
of each subject to withdraw and the right of each subject to confidential treatment of personal 
data will be respected at all times. The Investigator or Clinical Research Coordinator will record 
any subject’s withdrawal and the reason(s). 
 
 
 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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7.3 Study Size 
 
 
There will be a total of 100 Celtra Duo crowns placed.  The first 50 crowns will be placed 
consecutively using Celtra Duo in an oven-fired, glazed finish technique.  The second 50 crowns 
will be placed consecutively using Celtra Duo in a hand polished finish technique.  The sample 
size is according to the international standard represented by the criteria of the American Dental 
Association (ADA, Council on Scientific Affairs: Acceptance Program Guidelines “Restorative 
Materials”, March 1996) 
 
 
Celtra Duo > glazed 
Celtra Duo > polished 
Crowns 
50 
50 
 
 
7.4 Baseline - Restoration Placement 
 
 
A pre-operative questionnaire will be completed jointly by the patient, Clinical Research 
Coordinator, and treating doctor at the restorative appointment (copy enclosed in Appendix).  
This will establish the baseline information from which to compare the responses at subsequent 
times.  Teeth to be restored will be tested subjectively as described in the Data Collections 
section to follow.  The level of sensitivity will be recorded using a criterion-referenced rating 
scale.  The use of the scale will be explained to the patient prior to beginning the evaluation.  A 
Caries Risk Assessment will be completed for each patient at baseline based on the number of 
restorations the patient reports having received in the previous 12 months.  Low Caries Risk will 
be scored for patients having 0 or 1 restoration placed in the previous 12 months.  Moderate 
Caries Risk will be scored for patients having 2 or 3 restorations placed in the previous 12 
months.  And High Caries Risk will be scored for patients having 4 or more restorations placed 
in the previous 12 months. 
 
 
Pre-treatment  
 
 
A pre-treatment periapical radiograph (PAXR) will be used to evaluate the health of the 
tooth prior to initiation of treatment.  A new PAXR will be exposed at no cost to the patient if an 
existing PAXR dated within 1 month of the evaluation is not available for review.  The shade of 
the tooth to be restored will be determined prior to tooth preparation with a Classic Shade guide 
(Vita). 
 
 
Preparation  
 
 
All restorative procedures will be performed under standard local anesthesia with no 
increased risks incurred by patients participating in the study beyond those involved in routine 
dental treatment.  An Isolite System, or similar device, will be used to isolate the tooth for cavity 
preparation, optical imaging, and cementation of the restorations. 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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Full crown preparations will have a rounded shoulder design of at least 1.2 mm axial 
reduction, 2.0 mm reduction over functional cusps, and 1.5 mm reduction in the central fissure 
area.  If in the judgement of the operator, less than 1 mm of dentin thickness remains over the 
pulp, a flowable compomer resin (Dyractflow Compomer Flowable Restorative by Dentsply) 
may be selectively placed prior to completing the preparation.  
 
 
Restoration 
 
 
The manufacturer's instructions will be strictly adhered to in the imaging, design, and 
machining of the crowns using a CEREC OmniCam and MCX milling unit (Sirona Dental 
Systems) using the most current version of the software (4.31 as of December 2014). The crowns 
will be milled from prefabricated blocks of Celtra Duo (Dentsply), the zirconia-reinforced 
lithium silicate ceramic. 
 
 
The crown will be tried-in intraorally after milling to verify the proximal contacts, margin 
fit, and occlusal relationships prior to surface finishing.  The first 50 crowns to be completed will 
be glazed used an oven firing process for surface finishing.  The second group of 50 crowns to be 
completed will be hand polished with a series of diamonds abrasives, polishing wheels, and 
ceramic polishes for surface finishing. 
 
 
Crown Cementation 
 
 
The internal surfaces of the Celtra Duo crowns will be etched for 30 seconds with 4.9% 
hydrofluoric acid gel, rinsed for 20 seconds, and then air-dried with oil-free air.  Calibra silane 
coupler (Dentsply) will be applied to the prepared internal surface of all crowns for 60 seconds 
and dried for 5 seconds.   
 
 
All the crowns will be cemented using the most current marketed version of the 
manufacturer’s adhesive resin cement (SmartCem2/Dentsply) in two adhesive techniques.  All of 
the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement 
technique (Calibra Universal Cement/Dentsply.  This is the new product name for SmartCem2 
used in a self-adhesive technique.). The cavity preparation will be cleaned with a slurry of 
pumice and rinsed thoroughly for 10 seconds and dried carefully with care taken to prevent over-
drying the preparation. Calibra Universal Cement will be injected directly into the crown from 
the automix syringe.  The crown will be inserted to complete seating and the excess cement 
removed.  The crown will be light cured for 40 seconds from the facial, lingual and occlusal for a 
total cure of 2 minutes. 
 
 
All of the hand polished crowns will be cemented using an adhesive bonding technique 
using Prime & Bond Elect (Dentsply) with the most current version of the resin cement, 
SmartCem2 (Calibra Ceram/Dentsply is the new product name for SmartCem2 used with a 
separate bonding agent).  Prime & Bond Elect will be applied in an active scrubbing action to the 
tooth preparation for 20 seconds and lightly air dried.  The most current version of SmartCem2 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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PI: Dr DJ Fasbinder 
 
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Cement, Calibra Ceram, will be injected directly into the crown from the automix syringe.  The 
crown will be inserted to complete seating and the excess cement removed.  The crown will be 
light cured for 40 seconds from the facial, lingual and occlusal for a total cure of 2 minutes. 
 
 
Finishing and polishing will be initiated after visible light curing of the luting agent.  A 
series of diamond finishing burs, rubber abrasive points and cups, finishing strips, and diamond 
polishing pastes will be used for removal of excess cement, final contouring of the restoration, 
and adjustment of the occlusion.  A post-cementation periapical radiograph will be taken to 
document completion of the all-ceramic crown. 
 
8 Data Collection 
 
8.1 Post-Operative Sensitivity 
 
 
To evaluate the immediate post-operative sensitivity, patients will be contacted by 
telephone once a week after the initial appointment for four weeks or until the restoration is 
reported asymptomatic.  A criterion-referenced rating scale will be used to measure sensitivity.  
The phone interview will be used as a follow-up procedure to minimize recall loss as the patient 
is not required to return to the clinic.  During the phone interview a criterion-referenced rating 
will be made of functional tooth sensitivity using the following scale.  Patients will only be asked 
to return for an evaluation if they are having continued discomfort or any indication of premature 
occlusal contact. 
 
Sensitivity Criteria: 
1=  No sensitivity is experienced at anytime 
2=  Slight sensitivity is experienced occasionally but it is not uncomfortable 
3=  Moderate sensitivity is experienced intermittently and it is noticeably uncomfortable 
4=  Severe discomfort is noted routinely with cold or pressure stimulation 
 
 
8.2 Clinical Evaluation 
 
 
Two independent evaluators will examine all crowns in the study.  Clinical evaluations 
will be made at baseline, six months, one year, two years, three years, four years, and five years 
using written criteria based on modified USPHS criteria for margin discoloration, margin finish, 
margin adaptation, proximal contact, wear of opposing cusps, anatomical form, surface finish, 
and recurrent caries (see Appendix for criteria description).  Disagreements in evaluations will be 
discussed between the evaluators and a consensus judgment will be reached and recorded for 
every criteria. 
 
 
Intraoral digital color pictures at a 1:1.5 magnification will be taken to document pre-
operative, cavity preparation, restoration try-in, and post-operative conditions.  Facial and 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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PI: Dr DJ Fasbinder 
 
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occlusal views of the tooth will be documented for both the pre-operative and post-operative 
conditions.   
 
 
A postcementation quadrant impression will be made of each test restoration in a 
polyvinyl siloxane material and casts will be poured in an epoxy die material.  Casts will be 
made at the baseline, 6 months, 1 year, 2 year, 3 year, 4 year, and 5 year recall visit.   
 
 
Bite-wing radiographs (BWXR) of each test tooth will be reviewed at the three year 
recall.  A new BWXR will be taken at the recall appointment at no cost to the patient if BWXR 
dated within 6 months of the three-year recall are not available for review. 
 
 
8.3  Data Management 
 
 
Case Report Form (CRF) 
 
 
Data will be entered in the Case Report Form (CRF) by the investigator or assigned 
persons at the study center. The entries will be made with blue ball-point pen.  In case of 
necessary corrections, the wrong entry will be crossed out and the new entry will be written 
beside it.  No erasure is allowed for corrections.  Changes or corrections will be dated and 
initialized by the investigator or assigned person(s).   
 
 
Copies of the completed CRFs and Adverse Events/Incident Reports will be retained 
together with the investigator’s study file for a period of 2 years after completion of the study at 
the study center.   
 
 
8.4 Study Reports 
 
 
Progress reports on the investigation shall be submitted to the sponsor and the IRB at 
regular intervals. Progress reports to the sponsor will follow each recall evaluation period.  A 
final study report shall be submitted to the sponsor 9 months following termination or 
completion of the study.  Study completion for purposes of this requirement will be defined as 
completing assessments on the last subject. 
 
9 Adverse Events 
 
Any untoward effects either observed or volunteered by the subject during the course of 
the study either caused by or associated with the use of the test device will be documented as to 
onset, severity, duration, remedy and relatedness to the test device. Adverse events will be 
recorded in source documents and on case report forms. Any study staff member becoming 
aware of an adverse event must bring it to the attention of the PI as soon as possible.  Adverse 
events will also be reported to the University of Michigan IRB as current guidelines indicate. 
 
 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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9.1   Restoration Failures 
If a crown fails during the term of the study, the investigator will provide complete 
information on the manner of the failure and the proposed resolution to the study contact person 
at Dentsply.  Upon a determination that the crown failure did not result from other identifiable 
causes, and with Dentsply’s prior approval, the Investigator will make arrangements to replace 
the crown, or carry out appropriate alternative treatment (i.e. replacement with a fixed or 
removable partial denture) at Dentsply’s expense. Dentsply will not be responsible for any 
expenses incurred without its prior approval.  If a crown fails after the term of the study, 
Dentsply will not be responsible for any costs incurred in its repair or replacement.  Dentsply 
will have no responsibility for any other treatment a patient may receive during the term of the 
study or after the study has ended.  
 
 
In the event that study restorations should fail and require replacement, patients may elect 
to have a laboratory-fabricated restoration placed instead of another test restoration.  This would 
incur a significant cost to the investigators that is not included in the budget.  Replacement 
restorations would be fabricated in the Graduate General Dentistry Clinic at the prevailing 
charge per unit. Dentsply will pay the cost of these replacement restorations as described above. 
 
 
9.2  
Monitoring 
The sponsor will monitor this trial at timely intervals for compliance with this protocol, 
applicable FDA regulations and any conditions of approval imposed by the reviewing IRB.  This 
trial will also be monitored for safety related issues to determine whether any unreasonable risk 
to subjects develops.  Quality control measures include inspection of case report forms and 
source documents for accuracy and completeness. The Principal Investigator is ultimately 
responsible for the accuracy and completeness of case report forms, source documents, raw data 
listings and data tabulations.  Between monitoring visits, the Sponsor must be updated by the site 
as to study status by phone, fax or email.  
Dentsply may monitor the study at appropriate intervals by means of visits to the study 
site to evaluate study data and any photographs.  Study monitoring visits will involve review of 
the study status and any issues pertaining to it.  
 
10 Statistical Analysis 
 
 
After the clinical evaluation data is collected for baseline and each recall, the clinical 
ratings will be entered into a statistical management program and appropriate non-parametric 
tests will be run to verify significant differences.  A Wilcoxin test will be used to determine 
significant differences in the change of ratings from baseline to a given time period.  Each 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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PI: Dr DJ Fasbinder 
 
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criterion-referenced category will be analyzed independently.  At any given time period, 
significant differences in clinical evaluation ratings will be determined. 
 
11 Project Time Line 
 
 
The recruitment of patients and clinical placement of restorations will begin immediately 
upon approval and funding of the project.  It is anticipated to take 12 months to recruit and place 
the restorations required for the study.  An additional 5 years will be required to complete the 
five year recall examinations with an additional 9 months to complete the data analysis and final 
reports. 
Protocol Amendments and Discontinuing the Study 
After approval of the study protocol, any changes to the content of the study 
documentation must be described in an Amendment Form and be approved by the PI, Dentsply, 
and the reviewing IRB prior to implementation.  Any decision as to whether to prematurely stop 
the study will be taken jointly by the PI, Dentsply, and the IRB. Where early termination of the 
study occurs, subjects will receive appropriate follow up dental treatment. 
 
12 Equipment 
 
 
All instrumentation required for placement and clinical evaluation of the restorations is 
available through the Research Clinic of the Department of Cariology, Restorative Sciences, and 
Endodontics at the University of Michigan School of Dentistry.  Additional measurement 
instrumentation to include measuring microscopes, scanning electron microscope, computer 
analysis, and intraoral imaging equipment is available within the School of Dentistry. 
 
13 Facilities 
 
 
The Graduate General Dentistry Clinic maintains a two chair Clinical Research Unit for 
clinical research within the department.  A full time Clinical Research Coordinator is dedicated 
to the Clinical Research Unit as well.  She will coordinate and schedule all patient appointments, 
maintain recall schedules, and collate data collected.  A Certified Dental Assistant will also 
provide clinical support as well.  Additional dental materials and instruments as well as 
personnel support will be provided by the Graduate General Dentistry Clinic as needed. 
 
14 Additional Sponsorships: 
 
 
No other sponsorships are presently available or will be applied to this project. 
 
 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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15 Budget 
Insertion Phase – 100 crowns (50 crowns per 2 groups) 
Placement and Baseline Evaluation 
Requested 
Supplies and Equipment 
$6,850 
CEREC OmniCam System –supplies included milling diamonds, milling 
chamber lubricant, milling chamber filters 
 
Clinical supplies/materials for crown placement and baseline evaluation.   
 
Cementation kits and supplies to include XP Bond, Calibra cement, and 
Calibra Ceram cement kits and dispensers 
Provided by 
Dentsply 
Celtra Duo blocks (all shades; I10, I12, I14 sizes) 
Provided by 
Dentsply 
emaxCAD blocks (all shades; I12, I14 sizes) 
 
Impression materials, mixing guns, and mixing tips/intraoral tips 
 light body fast set & regular body 
Provided by 
Dentsply 
Model fabrication 
 
Personnel 
$67,000 
Operator – clinical treatment required to complete the onlays 
 
Dental Assistant - chairside assisting, protocol compliance, data recording, 
maintain materials and supplies, infection control maintenance 
 
Clinical Research Coordinator - organize study, recruit and appoint patients, 
order supplies, manage data and consent forms, catalogue photos, data 
verification and computer entry, train dental assistant, manage recall, 
monitor compliance to protocol 
 
Dr. Fasbinder - evaluator, principal investigator 
Oversee study, develop data and consent forms, recruit patients, clinical 
evaluations, data analysis, model analysis, prepare reports 
 
TBD Faculty (3) - evaluator, co-investigators 
Review study, recruit patients, clinical evaluations, statistical analysis, 
model analysis, review prepared reports 
 
Sub-Total 
$73,850 
University overhead (30%) 
$22,155 
Total 
$96,005 
 
 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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Recall Phase – 100 crowns 
6 months, 1 year, 2 year, 3 year 
Requested 
Supplies and Equipment 
$2,000 
Clinical supplies/materials for recall evaluation 
 
Impression materials and mixing tips/intraoral tips 
    light body fast set & regular body 
Provided by Dentsply 
Model fabrication 
 
Bitewing radiographs (year 3 only)  
 
Personnel 
$20,500 
Dental Assistant  
 
Clinical Research Coordinator  
 
Dr. Fasbinder - evaluator, principal investigator 
 
TBD Faculty (3) - evaluator, co-investigators 
 
Sub-Total 
$22,500 
University overhead (30%) 
$6,750 
Total 
$29,250 
 
 
 
Proposed Study – Project budget for CROWNS 
Requested 
Placement of 100 crowns 
$96,005 
6 month recall 
$29,250 
1 year recall 
$29,250 
2 year recall 
$29,250 
3 year recall 
$29,250 
Total 
$213,005 
 
 
Funding for years four and five recalls are to be negotiated after the second year recall has been 
completed. 
 
Budget time-line 
It will take 12 months to recruit the patients and deliver the crowns for the study.  The 1 year 
recall will occur in the second year of the study, and similarly for future recalls in that the 2 year 
recall will occur in the third year of the study and continuing.  This will result in a total time of 6 
years required to place and complete the 5 year recall of the crowns with an additional 6-9 
months needed to complete the data analysis and final report for the project. 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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Appendix 
 
Patient Questionnaire 
Clinical Evaluation Criteria 

Clinical Investigation Proposal: Chairside CAD/CAM Zirc-Lithium Silicate Crowns 
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INITIAL QUESTIONNAIRE 
 
Patient: 
 
 
Date:  
 
 
1.  Birthdate (month-day-year)   
 
 
2.  Gender: 
male  
 
female  
 
 
3.  Has there been any sensitivity on the tooth to be restored? 
yes  
 
no 
 
 
 
4. Caries Risk Assessment 
 
Low 
 
 
0-1 carious lesions in the last 24 months 
 
Moderate 
 
 
2-4 carious lesions in the last 24 month 
 
High 
 
 
 
4+ carious lesions in the last 24 month (disqualifies) 
 
6. Tooth/Teeth number to be restored (crown):  
 
 
  
 
7. Pre-operative vitality; verify with cold test:   Vital       Devital    (circle one) 
 
8. Reason tooth needs restoration:    
 
 
fractured cusp  
 
caries 
 
 
 
 
esthetics 
 
 
fractured restoration 
 
 
 
 
fracture lines  
 
open margins 
 
 
 
 
severe wear 
 
 
cervical overhang 
 
 
 
 
poor contour 
 
 
open proximal contact  
 
 
9. Verify pre-operative PAXR for test tooth; less than 6 months old.  
 (initials) 
 
10. Occlusion – at least one centric stop per tooth. 
 
 (initials) 
 
11. Informed Consent form signed. 
 
 (initials) 
 
12. Pre-operative Shade:  
 
 
   (photograph shade tab/s with control tooth) 
 
13. Opposing Tooth: (photograph opposing teeth; with and without occlusal contacts marked) 
Restorative material:  
 
 
 
 
 
 
Evidence of wear facets:  yes          no    
Evidence of lateral interferences:   
 
 
 
  
Is patient a bruxer?:  
 
 
 
 
 
 
 
 
 
 
 

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CLINICAL EVALUATION CRITERIA 
Gingival Index (for crowns) 
Gingival score (visual) for gingival area nearest to the crown margin; evaluate without disclosing. 
(Gingival scores will be based upon the standard Loe & Silness Index, 1963)  
 
score 0 = normal gingiva  
score 1 = mild inflammation - slight change in color, slight edema, no bleeding  
score 2 = moderate inflammation - redness, edema and glazing, bleeding on probing  
score 3 = severe inflammation - marked redness and edema, ulceration, spontaneous bleeding  
 
Plaque Index (for crowns) 
Plaque score (visual) for facial gingival area nearest to the crown margin; evaluate without disclosing. 
(Plaque scores will be based upon the standard Silness & Loe Index, 1964)  
 
score 0 = no plaque detectable in the gingival area 
score 1 = plaque recognized only by running tip of probe across tooth surface at gingival crest  
score 2 = moderate accumulation of plaque visible along gingival margin and adjacent tooth  
score 3 = abundance of plaque visible along gingival margin and adjacent tooth 
 
Color Match (with control tooth, indirect lighting, without magnification) 
Rating  
 
Tooth and restoration have an ideal color match; can distinguish restoration with some difficulty 
Alpha 
 
Readily perceptible mismatch in color; general match 
Bravo 
 
Obvious mismatch in color between tooth and restoration; unacceptable for cementation 
Charlie 
 
Margin Discoloration (evaluated with tooth dry) 
  
 
No evidence of margin discoloration 
Alpha 
 
Surface stain along less than 50% of exposed margin 
Bravo-1 
 
Surface stain along greater than 50% of exposed margin 
Bravo-2
 
Penetrating discoloration of exposed margin 
Charlie 
 
Surface Finish (surface of the restoration as viewed under magnification) 
 
Smooth, highly polished to finely granular  
Alpha 
 
Gritty, moderate rough but uniform texture 
Bravo 
 
Rough or pitted, visible evidence of significant pits and voids 
Charlie 
 
Evidence of surface crazing with no loss of ceramic or mobile pieces 
Delta 
 
 
Anatomic Form (general contour) 
 
Restoration is continuous with existing anatomic form 
Alpha 
 
Restoration is discontinuous with existing anatomic form but missing 
Bravo 
 
 
material is not sufficient in size to expose dentin 
 
Restoration is discontinuous with existing anatomic form and missing 
Charlie 
 
 
material is sufficient in size to expose dentin 
 
 
Proximal Contact 
 
Firm resistance to passage of floss with ideal breadth of contact area 
Alpha 
 
Light resistance to passage of floss or notable variance in breadth of contact area;  
Bravo 
 
 
shim stock will pass through contact 
 
Contact visibly open with passage of one thickness of articulating paper (blue) 
Charlie 
 
Caries 
 
No evidence of caries 
Alpha 
 
Evidence of recurrent caries at crown margin; repairable without compromise to crown 
Bravo 
 
Evidence of recurrent caries at crown margin; not repairable, crown requires replacement 
Charlie 
 

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Margin Adaptation (margin integrity) 
 
No visible evidence of crevice formation along cavosurface margin 
 
 
explorer does not catch when drawn across the margin 
Alpha-1 
 
No visible evidence of crevice formation along cavosurface margin 
 
 
Margin is detectable along less than 50% of cavosurface margin; and less than 1 mm in depth  
Alpha-2 
 
No visible evidence of crevice formation along cavosurface margin 
 
 
Margin is detectable along more than 50% of cavosurface margin; and less than 1 mm in depth Alpha-3 
 
Evidence of crevice formation (penetrable) along less than 50% of the cavosurface margin;  
 
 
greater than 1 mm in depth 
Bravo-1 
 
Evidence of crevice formation (penetrable) along greater than 50% of the cavosurface margin;  
 
 
greater than 1 mm in depth 
Bravo-2 
 
Evidence of crevice formation exposing dentin to the axial or pulpal floor 
Charlie 
 
Restoration Fracture 
 
No evidence of restoration fracture 
Alpha 
 
Evidence of restoration fracture with a missing piece considered polishable 
Bravo 
 
Evidence of restoration fracture with a missing piece considered repairable 
Charlie 
 
Fracture of the restoration requiring replacement of the restoration 
Delta 
 
Sensitivity 
 
No sensitivity is experienced at any time 
Alpha 
 
Slight sensitivity is experienced occasionally but is not uncomfortable 
Bravo 
 
Moderate sensitivity is experienced intermittently and is noticeably uncomfortable 
Charlie 
 
Severe discomfort is noted routinely with cold or pressure stimulation 
Delta