Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement
Phase: NA
Conditions: Dental Cements, Caries,Dental
Sponsor: Solventum US LLC

 
 
 
 
Clinical Performance of Chairside CAD/CAM 
Restorations using a New Adhesive Cement 
 
3M ID# CR 19/03 
 
NCT04279574 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Joint Copyright University of Michigan and 3M 2019: 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 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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form or by any means; electronic, mechanical, photocopying, recording, or otherwise, without prior permission of Dr. 
Dennis J. Fasbinder, University of Michigan, USA and  3M, St Paul, MN 55144-1000 . 
 
1 Investigation Title 
 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
2 Investigators 
Dennis J. Fasbinder, DDS 
Clinical Professor 
 
Gisele Neiva, DDS, MS 
Clinical Professor 
 
Steven J. Sterlitz, DDS, MS 
Assistant Clinical Professor 
 
Donald Heys, DDS, MS 
Professor of Dentistry 
 
Ronald Heys, DDS, MS 
Associate 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 
email: Dr. Fasbinder  djfas@umich.edu 
  
 
3 Sponsor 
3M Deutschland GmbH 
3M Oral Care  
ESPE Platz  
82229 Seefeld, Germany 3M  
 
Study Monitor: Rolf Halvorson PhD, Sr. Clinical Research Specialist  
HCBG Clinical Operations 
3M Center, 270-3A-04 | St. Paul, MN 55144-1000 | United States 
Office: +1 651 733 3384 
rhhalvorson@mmm.com 
 
Clinical Project Manager: Dr. Bernadette Rauch  

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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3M Oral Care, 3M Central Europe Region 
3M Deutschland GmbH | ESPE Platz | 82229 Seefeld, Germany 
Office: +49 8152 700 1482  
bernadette.rauch@3m.com 
 
 

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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4 Summary of Objectives and Design 
A wide variety of restorative materials are available for dental restorations.  The most 
popular current materials include glass ceramics and full contour zirconia.  Glass ceramic 
materials are generally preferred for their high translucency mimicking enamel-like esthetics of 
natural teeth and zirconia is preferred for high strength applications.  Both of these materials are 
available for clinical treatment using chairside CAD/CAM technology. 
The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened 
the opportunity for chairside full contour zirconia crowns by decreasing sintering times for 
zirconia to under 30 minutes.  3M Chairside Zirconia (3M) was marketed in 2019 and offers 
improved esthetics and high strength for monolithic zirconia restorations with an efficient 
processing time. 
Chairside CAD/CAM restorations are generally delivered with adhesive resin cements.  The  
cement may or not require pre-treatment of the tooth by etching or a bonding agent.  This creates 
potential confusion for a clinician as to what the optimal material selection and treatment 
process should be.  A new adhesive resin cement (Suglue 3/3M) is the latest generation of dual 
cured resin cements from 3M with the innovation to use different tooth pre-treatment options, 
self-etch, selective enamel etch, or total etch depending on the type of restoration.  This 
simplifies the selection process for delivery of restorations by minimizing the amount of different 
materials required. 
This investigation will be a longitudinal clinical trial to study the long-term clinical 
performance of a new adhesive resin cement for chairside CAD/CAM restorations.  Lithium 
disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a 
selective enamel etch technique with a new generation universal adhesive based on Scotchbond 
Universal Adhesive (3M) and a new generation resin adhesive cement based on RelyX Ultimate 
(3M).  Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-
adhesive technique with the new generation adhesive cement.  All restorations may be followed 
up to five years of service.  

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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5 Specific Aims 
The specific aims of this project are: 
 
1.  Evaluate the short-term post-operative sensitivity associated with a self-etching resin 
cement for adhesive luting of chairside zirconia crowns. 
 
2. Evaluate the short-term post-operative sensitivity associated with the adhesive luting 
technique for ceramic onlays using a selective enamel etch technique and a universal adhesive 
and dual cure resin cement. 
 
3.  Evaluate the longitudinal clinical performance of lithium disilicate ceramic onlays and full 
contour zirconia crowns for up to five years of clinical service, for a minimum of 3 years.  The 
onlays and crowns will be evaluated with FDI criteria (Hickel et al., 2007 and 2010) for esthetic 
properties include surface luster, surface staining, margin staining, color match and 
translucency;  functional properties include anatomical form, material fracture, retention, margin 
adaptation, occlusal contour and wear, and proximal contact and contour; and biological 
properties include post-operative sensitivity, recurrence of caries, erosion, abfraction as well as 
gingival index, and plaque index. 
 
6 Research Plan: Methods and Materials 
 
6.1 Subjects 
 
 
The patient population will be selected from current patients under clinical treatment at 
the University of Michigan Dental Clinics.  Patients need to volunteer for the study and must sign 
the informed consent. 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 premolar or molar. Each lesion or defective restoration 
should exhibit sufficient size to extend at least one-half the intercuspal width of the tooth 
requiring an onlay or full crown restoration. The onlays may contain between one and three cusps 
on the selected tooth as long as an occlusal margin will be present.  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 premolar teeth.  Exclusion criteria will include: 

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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Devital or sensitive teeth 
 
Teeth diagnosed with symptoms of incomplete tooth fracture 
 
Teeth with prior endodontic treatment of any kind 
 
Teeth with a history of direct or indirect pulp capping procedures 
 
Subjects with uncontrolled bruxism or parafunctional habits 
 
Subject has known allergies to any product used during this study  
 
Subject will not be available for the study duration of 5 years 
Subjects with significant untreated dental disease to include periodontitis and rampant caries 
 
Pregnant or lactating women 
 
 
6.2 Informed Consent 
 
 
The Health Sciences 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 finalized, and funding is provided.  Patients who are eligible for the study will be 
screened by the 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.  (A copy is included in 
the Appendix).  Patients will be charged $375 for each restoration.  This will fund an incentive 
fund for patient recalls.  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 as part of routine, standard 
of care for monitoring dental restorations.  Specific study data is not dependent on the 
radiographs. 
 
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 PI will record any subject’s withdrawal and the reason(s). 

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Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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6.3 Study Size 
 
 
There will be 40 zirconia crowns and 40 ceramic onlays placed.  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). 60 patients will be enrolled in the study.  
 
 
6.4 Study Overview 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
T3 (2 years ± 1 month)
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
Pre-Screening
Identification of subjects with the need and Indication for onlays and/or crowns
Baseline
Report 
Optional: T5 (5 years ± 1 month)
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
Screening and Enrolment
Patient information about the study and Signing Informed Consent/HIPAA 
40 restorations per indication will be placed 
Subjects meeting inclusion criteria enrolled based on inclusion/exclusion criteria
Restoration Treatment and baseline evaluation including post-operative sensitivity
Placement of Restorations by 3 trained operators; Calibration of evaluators 
Post-operative sensitivity will be assessed via phone interviews for 4 weeks
T1 (6 month ± 1month) 
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
T2 (1 year ± 1 month)
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
Optional: T5 (4 years ± 1 month)
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
T4 (3 years ± 1 month)
Evaluation of study restorations according to modified FDI criteria by 2 evaluators;  
1 Year
Report
2 Year
Report
3 Year
Report
4 Year
Report
5 Year
Report

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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6.5 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  
 
 
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.  An Optragate may also be 
used to retract tissues during digital imaging. 
 
 
Onlay Preparation 
 
 
The occlusal walls of the chairside CAD/CAM onlay preparation will be tapered 10o – 12o 
from the cavosurface to the pulpal floor to ensure distinct occlusal margins.  The flare of the 
proximal boxes will conform to standard criteria with proximal walls exposed for convenience in 
finishing the margins.  There will be no bevels on margins and all floors and walls will be relatively 
perpendicular to the cavosurface.  Any additional design modifications will be in accord with the 
unique parameters of the computergraphic design software.  The onlay will have a 1.5 mm 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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minimal thickness in the central fissure and 2.0 mm minimal thickness over functional cusps.  If 
in the judgement of the operator, less than 1.0 mm of dentin thickness remains over the pulp, a 
glass ionomer base (Vitrebond/3M) may be selectively placed prior to completing the 
preparation.  
 
 
Crown Preparation 
 
 
The occlusal walls of the chairside CAD/CAM crown preparation will be tapered 10o – 12o 
with the axial-pulpal angles rounded.  There will be no bevels on margins.  Any additional design 
modifications will be in accord with the unique parameters of the computergraphic design 
software.  The crown will have an axial thickness of greater than 0.8 mm, 1.0 mm minimal 
thickness in the central fissure, and 1.5 mm minimal thickness over functional cusps.  If in the 
judgement of the operator, less than 1.0 mm of dentin thickness remains over the pulp, a glass 
ionomer base (Vitrebond/3M) may be selectively placed prior to completing the preparation. 
 
 
Restoration Fabrication 
 
 
The manufacturer's instructions will be strictly adhered to in the imaging, design, and 
manufacturing of the onlays and crowns using the CEREC system (Dentsply Sirona).  Following 
imaging of the tooth preparation with the CEREC PrimeScan, the onlay or crown will be designed 
using the CEREC software (5.0).  The onlays will be milled from prefabricated blocks of IPS 
emaxCAD (Ivoclar), a lithium disilicate ceramic.  They will be stained, glazed and crystallized per 
manufacturer’s instructions to create the final contour and finished surface.  The crowns will be 
milled from prefabricated blocks of 3M Chairside Zirconia (3M) and then sintered in the 
SpeedFire oven (Dentsply Sirona) per manufacturers guidelines.  The crowns will be hand 
polished to create the final contour and finished surface prior to restoration delivery. 
 
 
Crown Cementation 
 
 
Once the crown is ready is for cementation, the internal surface of the crown will be 
cleaned with air/water spray and air dried with oil-free air.   
All of the zirconia crowns will be cemented with a dual cure resin cement, Suglue 3 (3M).  
Suglue 3 is the latest generation of dual cure adhesive resin cement based on the previously 
marketed RelyX Unicem 2/RelyX Ultimate adhesive cement chemistry. The internal surfaces of 
the zirconia crown will be air abraded with 30 m aluminum oxide (CoJet sand/3M) at a pressure 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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of 30 psi to create a uniform, matte surface.  The crown will be cleaned with alcohol, rinsed with 
water, and dried with oil-free air.   
 
 
The cavity preparation will be thoroughly cleaned with water spray for 10 seconds and 
dried carefully with care taken to prevent over-drying the preparation leaving a glossy surface to 
the tooth.  Suglue 3 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 10 seconds from the facial, lingual and occlusal for a total cure of 30 seconds. 
 
 
Onlay Cementation 
 
 
The PVS replica technique will not be used for the onlays since onlay preparations are not 
as uniform as crown preparations with inconsistent areas for measurement between onlays.  The 
internal surfaces of the IPS emaxCAD onlays will be etched for 20 seconds with 4.9% 
hydrofluoric acid gel, rinsed for 20 seconds, and then air dried with oil-free air.  ADH-19 will be 
actively applied (scrubbed) with the disposable applicator to the etched ceramic surface for 20 
seconds then lightly air dried until there is no movement and the solvent has evaporated 
completely. 
 
 
The cavity preparation will be etched for 20 seconds with 37% phosphoric acid 
(Scotchbond Universal Etchant/3M), rinsed thoroughly with water, and lightly air dried leaving a 
moist surface that is glossy in appearance.  ADH-19 is the latest generation of universal bonding 
agents from 3M based on the Scotchbond Universal Adhesive (3M) chemistry.  A thin coating of 
ADH-19 universal bonding agent will be actively applied (scrubbed) with a disposable applicator 
and air dried until there is no movement and the solvent has completely evaporated.  Suglue 3 
Cement will be injected directly into the tooth preparation from the automix syringe. The onlay 
will be inserted into the cement to complete seating and the excess cement removed.  All onlays 
will be light cured for 10 seconds from the facial, lingual and occlusal for a total cure of 30 
seconds. 
 
 
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. 

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Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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7 Data Collection 
 
7.1 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 occasionally, and it is noticeably uncomfortable 
4=  Severe discomfort is noted routinely with cold or pressure stimulation 
 
 
7.2 Clinical Evaluation 
 
 
Two independent evaluators will examine all restorations in the study.  Clinical 
evaluations will be made at baseline, six months, one year, two years and three years. If feasible, 
subjects will return for additional follow-up visits at four and five years. Evaluation criteria are 
based on FDI criteria (Hickel et al., 2007 and 2010) for esthetic properties include surface luster, 
surface staining, margin staining, color match and translucency;  functional properties include 
anatomical form, material fracture, retention, margin adaptation, occlusal contour and wear, and 
proximal contact and contour; and biological properties include post-operative sensitivity, caries, 
gingival index, and plaque index  (see Appendix for FDI criteria description).  Disagreements in 
evaluations will be discussed between the evaluators and a consensus judgment will be reached 
and recorded for every criteria. 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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Intraoral digital color pictures at a 1:1.5 magnification will be taken to document pre-
operative, cavity preparation, and post-operative conditions.  Facial and occlusal views of the 
tooth will be documented for both the pre-operative and post-operative conditions.   
 
 
A post-cementation quadrant digital scan will be made of each test restoration using the 
OmniCam.  Digital files will be recorded at the baseline, 6 months, 1 year, 2 year and 3 year.  
Optionally also at 4- and 5-year recall visits.  Bite-wing radiographs and periapical radiographs of 
each test tooth will be available preoperatively and at the three-year recall for routine, standard 
of care monitoring of the restorations.  
 
 
7.3  Data Management 
 
 
Case Report Form (CRF) 
For this study, all required data will be entered into the electronic CRFs (eCRFs), by the end of 
each day by Anja Buschhaus, the Research Clinic Coordinator at the University of Michigan. 
Approval is required by the principal investigator Dennis J Fasbinder. Up to 50 sets of paper 
copies of the CRFs may be provided to the site in the event that computer access is limited. If 
paper CRFs are used, they are the source data and must be entered into the eCRF by the end of 
each day. If study-related data are recorded for the first time directly into the eCRF, then the 
eCRF is the source document. Completed paper and eCRFs will be reviewed by the site monitor 
to ensure accuracy and consistency of subject data. Any discrepancies found during CRF review 
are to be clarified by the Investigator or designee.  
In case paper format would need to be used 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).  The documentation of each patient visit 
(baseline, follow-ups) must be signed and dated by the conducting investigator. If paper versions 
would be used the data would be directly entered into Clindex for electronic data capture by Anja 
Buschhaus.  

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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The completed CRFs and Adverse Events/Incident Reports will be retained together with 
the investigator’s study file for a period of 10 years after completion of the study at the study 
center.   
3M intends to use electronic data capture (eDC) software (Clindex) for this study. Sites will be 
trained on the eDC software prior to study enrollment. Each site will be provided with a manual, 
including instructions on how to complete the CRFs and how to make CRF corrections. Data may 
be recorded onto data collection sheets (provided by 3M) prior to data entry or may be entered 
directly into the eDC system. Once the forms are completed, the monitor will review the CRFs to 
assure accuracy and completeness. The Investigator must review and sign the CRFs for each 
subject in a timely fashion following completion. 
 
 
 
Adverse Event / Adverse Device Effect Form – Incident/Near Incident form 
 
 
In case of occurrence of any Adverse Event or Adverse Device Effect the appropriate form 
provided by 3M has to be filled in by the investigator.   In case of any near incident or any event 
that could lead or led to any medical hazard for the investigator (user) of the investigational 
device the Incident/Near Incident form provided by the sponsor has to be filled in by the 
investigator.  
Any adverse reactions to the treatment provided as part of the study will be fully 
investigated and recorded on the Adverse Event/Adverse Device Effect form (See Appendix), 
including details of the appropriate clinical action taken. An adverse event is defined as any 
unintended adverse experience associated with the study materials or study procedures that 
results in an unplanned medical assessment or treatment or changes the risk to subjects.  
 
Restoration Failures 
If a crown or onlay 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 3M.   Failures associated with the bonding agent, cement, crowns and onlays that may be 
expected in this study include: 
 loosening or complete loss of the crown or onlay 

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Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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 fracture and/or chipping of the crown or onlay 
 surface roughening or discoloration of the crown or onlay 
Upon a determination that the crown or onlay failure did not result from other identifiable 
causes, and with 3M’s prior approval, the Institution will make arrangements to replace the 
crown or onlay or carry out appropriate alternative treatment (i.e. replacement with a fixed or 
removable partial denture) at 3M’s expense. 3M will not be responsible for any expenses incurred 
without its prior approval.  If a crown or onlay fails after the term of the study, 3M will not be 
responsible for any costs incurred in its repair or replacement.  3M will have no responsibility for 
any other treatment a patient may receive during the term of the study or after the study has 
ended.  
 
 
 
Monitoring 
 
 
Monitoring visits will take place at the study center.  During these visits, questions on the 
study conduct will be discussed and the study documentation will be reviewed. The study 
monitor will check whether the Clinical Investigation Plan was followed and whether the 
investigational device was applied according to the Instructions for use.  The monitor will verify if 
appropriate patient consent is available for each patient and that it was included before 
enrolment. 
 
 
Furthermore he/she will check the availability, completeness, logicalness, accuracy and 
legibility of certain study documents, the CRFs and the Adverse Event/Incident forms. The 
occurrence of any new Adverse Event/Adverse Device Effect/(near) incident will be reported in 
the monitoring report and copies of the forms will be collected.  Certain data in the CRFs will be 
verified with source documents (patient files).  
The study will be monitored at appropriate intervals by the study monitor, or his/her 
designee, 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. All 
Informed Consent forms, HIPAA forms will be reviewed for signatures; all CRF’s will be reviewed 
for completeness of data entry and that the study protocol is being followed; the subjects’ 

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profiles will be checked to ensure they meet the inclusion and exclusion criteria. Materials will be 
checked for adequate storage and sufficient quantity to meet the study needs.  
 
 
Data collection and Data corrections 
 
 
During monitoring, CRFs will be checked for accuracy, legibility, logicalness and 
completeness, that all patients have given informed consent, meet selection criteria, and have 
had treatments randomly allocate in accordance with the study protocol.  Resulting changes in 
the data will be initialized and dated by the person who changed them.  If all open questions 
could be cleared with the investigator, copies of the signed Adverse Event/Incident forms will be 
provided for the Study Monitor’s file.  Data entry will be done by Anja Buschhaus, Research Clinic 
Coordinator of the Cariology, Restorative Sciences Clinical Research Unit. 
 
8 Statistical Analysis 
            In general, all analyses will be conducted separately by type of restoration; onlay or crown. 
Means and standard deviations were calculated for all clinical measurements and assessments. 
Categorical variables were summarized in frequency distributions.  
There will be two datasets analyzed at each recall period; (1) one dataset consisting of subjects 
who were enrolled up to and including that recall period, and (2) one dataset consisting of all 
subjects with baseline data. In the second dataset (2) primary and secondary outcome variables 
which are missing will be imputed using the method of last observation carried forward (LOCF), 
wherein the last observed values for that variable will be carried forward to all remaining 
timepoints. 
The primary analysis for this study will be the percent of intact/surviving restorations from 
baseline to the end of each recall period. This will be estimated using the Kaplan-Meier method, 
there will be no direct comparisons within this analysis. The median survival time of a restoration 
will be presented alongside survival curves. 
The secondary analyses for this study will relate to the FDI criteria for esthetic properties 
including surface luster, surface staining, margin staining, color match and 
translucency;  functional properties including anatomical form, material fracture, retention, 

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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margin adaptation, occlusal contour and wear, and proximal contact and contour; and biological 
properties including post-operative sensitivity, caries, gingival index, and plaque index  (see 
Appendix for FDI criteria description). The FDI criteria will be assessed at each recall period 
versus their respective baseline scores for a particular restoration within a particular subject. FDI 
criteria which are measured in an ordinal-discrete manner will be assessed using the Wilcoxon-
signed rank test. Criteria which are measured continuously such as PI and GI will be assessed 
using the student's t-test, in the event that the PI and GI scores do not appear to be Normally 
distributed this assessment will shift to be done using the Wilcoxon-signed rank test. 
A two-sided alpha of 0.05 will be used for all comparisons. There will be no adjustments made for 
multiplicity. 
All statistical analyses will be performed e.g. using SAS version 9.4 or above (SAS Institute, Cary, 
NC).  
 
9 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 9-12 months to recruit and 
place the restorations required for the study. 
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, 3M, and 
the reviewing IRB prior to implementation.  Any decision as to whether to prematurely stop the 
study will be taken jointly by the PI, 3M, and the IRB. Where early termination of the study occurs, 
subjects will receive appropriate follow up dental treatment. 
 
10 Equipment 
 
 
A CEREC system including a CEREC OmniCam and PrimeScan, MCX mill, Programmat 
oven, and SpeedFire oven is available at the University of Michigan for use during the study.  All 
other instrumentation required for placement and clinical evaluation of the restorations is 
available through the Research Clinic of the Department of Cariology, Restorative Sciences, and 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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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. 
 
11 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. 
 
12 Additional Sponsorships: 
 
 
No other sponsorships are presently available or will be applied to this project. 
 
 
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. 3M will pay the cost of these replacement restorations in accordance with Section 7.3 
Restoration Failures. 
 
 
 
 
 
 
 
 
 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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13 References 
Hickel RPA, Tyas M, Mjor I, Bayne S, Peters M, Hiller K-A, Randall R, Van Herle G, Heintze SD. FDI 
World Dental Federation: clinical criteria for the evaluation of direct and indirect 
restorations—update and clinical examples, Clin Oral Invest 2010: 14: 349-366. 
Hickel RPA, Bayne S, Heintze SD, Mjor I, , Peters M, Rousson V, Randall R, Schmalz G, Tyas M, 
VanHerle G.Recommendations for conducting controlled clinical studies of dental 
restorative materials, Clin Oral Invest 2007: 11: 5-33. 
Löe, H. The Gingival Index, the Plaque Index and the Retention Index Systems. Journal of 
Periodontology, Vol. 38, No. 6 (November-December 1967), pp. 610-6, ISSN 0022- 
3492 
Löe, H.; Silness, J. Periodontal disease in pregnancy. Acta Odontologica Scandinavica, Vol. 21, 
(December 1963), pp. 533-551, ISSN 0001-6357.  
Silness J, Loe H (1964). Periodontal disease in pregnancy 2. Correlation between oral hygiene and 
periodontal condition. Acta Odontol Scand; 22: 121-135. 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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14 Budget 
Insertion Phase – 80 restorations (40 onlays and 40 crowns) 
Placement and Baseline Evaluation 
Requested 
Supplies and Equipment 
$6,967
CEREC System – milling diamonds, milling unit lubricant 
Clinical supplies/materials 
Instruments and materials for restoration fabrication, finishing 
Curing light (3M preferred unit for the study) 
Provided by 3M
Suglue 3 cement kits, ADH-19 kits and dispensers 
Provided by 3M
IPS emaxCAD mill blocks (variety of shades; I12, I14 sizes) 
3M Chairside Zirconia blocks (all shades; I14 sizes) 
Provided by 3M
Personnel 
$65,500
Operator – clinical treatment required to complete the onlays and crowns 
Dental Assistant - chairside assisting, protocol compliance, 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, computer entry, manage recall, monitor protocol compliance 
Dr. Fasbinder - evaluator, principal investigator 
Oversee study, develop data and consent forms, train clinicians, recruit 
patients, clinical evaluations, data analysis, model analysis, prepare reports 
TBD Faculty (3) - evaluators, co-investigator clinicians 
Review study, recruit patients, clinical treatment, clinical evaluations, review 
prepared reports 
Statistician – data coordination, statistical analysis 
Sub-Total
$72,467
University overhead (30%)
$20,808
Total
$93,275
 
 
Recall Phase - 6 months, 1 year, 2 year, 3 year 
Requested 
Supplies and Equipment 
$2,225
Clinical supplies/materials for recall evaluation 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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Personnel 
$20,500
Dental Assistant  
Clinical Research Coordinator  
Dr. Fasbinder - evaluator, principal investigator 
TBD Faculty (3) - evaluator, co-investigators 
Total 
$22,725
University overhead (29%) 
$6,590
Subtotal per recall 
$29,315
4 recalls (Total above x 4) 
$117,260
 
 
Proposed Study – Budget for Recalls 
Requested 
After contract is signed 
$49,999 
After receipt of baseline report by 3M 
$40,134 
After receipt of 1 year recall report by 3M 
$40,134 
After receipt of 2 year recall report by 3M 
$40,134 
After receipt of 3 year recall report by 
3M/final report 
$40,134 
University overhead (30%) 
$6,765 
Overall sum 
$ 210,535 
 
Potential recalls for years four and five are to be negotiated after the second-year recall. 
 
 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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Appendix 
 
Subject Enrollment 
Pre-Operative Questionnaire 
FDI Clinical Evaluation Criteria 
Adverse Event Records 
 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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SUBJECT ENROLLMENT 
 
 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
Page 25 
 
FDI CLINICAL EVALUATION CRITERIA 
Gingival Index 
Gingival score (visual) for gingival area nearest to the restoration 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 
Plaque score (visual) for facial gingival area nearest to the restoration 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 
 
A. Aesthetic properties 
1. Surface lustre
2a. Surface Staining
2b. Margin Staining
1. Clinically excellent /  
very good 
1.1 Lustre comparable to 
enamel, Smooth, high gloss 
surface 
2a.1 No surface stain
2b.1 No margin stain
2. Clinically good
(after polishing  
probably  very good) 
1.2.1 Slightly dull, not 
noticeable from speaking 
distance. 
1.2.2 Some isolated pores. 
2a.2 Minor surface staining, 
easily removable by gentle 
polishing (prophy cup) 
2b.2 Minor marginal 
staining, easily removable 
by gentle polishing (prophy 
cup) 
3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects 
but not adjustable w/o 
damage to the tooth) 
1.3.1 Dull surface but 
acceptable if covered with 
film of saliva. 
1.3.2 Multiple pores on 
more than one third of the 
surface. 
2a.3 Moderate surface 
staining that may also present 
on other teeth, not 
aesthetically unacceptable. 
 
2b.3 Moderate marginal 
staining, not aesthetically 
unacceptable.(aggressive 
removal of surface) 
4. Clinically 
unsatisfactory 
(but repairable) 
1.4.1 Rough or pitted 
surface, cannot be masked 
by saliva film, simple 
polishing is not sufficient. 
Further intervention 
necessary. 
1.4.2 Voids. 
2a.4 Surface stain not 
removed by gentle polishing, 
penetrates crown surface, 
major intervention necessary 
for improvement. (aggressive 
removal of material + adding 
material ) 
2b.4 Pronounced margin 
staining, Deeper 
penetration of the margin, 
major intervention 
necessary for 
improvement. (aggressive 
removal of material + 
adding material ) 
5. Clinically poor
(replacement 
necessary) 
1.5 Very rough, 
unacceptable plaque 
retentive surface. 
2a.5 Severe Subsurface 
staining within the body of the 
crown, not accessible for 
intervention, removed only by 
replacement of crown 
2b.5 Deep and widespread 
margin staining that 
penetrates margin, not 
accessible for intervention 
removed only by crown 
replacement 

3M ID# CR 19/03, Version: 1 
 
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Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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A. Aesthetic properties 
3. Colour match and 
translucency 
4. Aesthetic anatomical form 
1. Clinically excellent /  very good
3.1 Good colour match, no 
difference in shade and/or 
translucency. 
4.1 Form– comparable to natural 
tooth anatomy. 
2. Clinically good
(after polishing  probably  very good) 
3.2 Minor deviations in shade 
and/or translucency 
4.2 Form is only slightly deviated from 
natural tooth anatomy. 
3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects but not 
adjustable w/o damage to the 
tooth) 
3.3 Distinct deviation but 
acceptable. Does not affect 
aesthetics: 
3.3.1 more opaque 
3.3.2 more translucent 
3.3.3 darker 
3.3.4 brighter 
4.3 Form deviates from the natural 
anatomy but is aesthetically 
acceptable. 
4. Clinically unsatisfactory
(but repairable) 
n.a. 
4.4. Form is affected and 
unacceptable aesthetically. 
Intervention/correction is necessary. 
5. Clinically poor
(replacement necessary) 
3.5 Unacceptable. Replacement 
necessary. 
4.5 Form is unsatisfactory and/or 
lost. Repair not feasible / reasonable, 
replacement needed. 
B. Functional properties 
5a. Fracture of material 
5b. Retention
6. Marginal adaptation
1. Clinically excellent / very 
good 
5a.1 No fractures / cracks
5b.1 Restoration in 
place 
6.1 Harmonious outline, 
margins not detectable  
2. Clinically good
  
5a.2 Small hairline crack.
n.a.
6.2 margins detectable: Slight 
ditching, slight step/flashes, 
minor irregularities.  
3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects but not 
adjustable w/o damage) 
5a.3 Two or more or larger 
hairline cracks and/or 
material chip fracture not 
affecting the marginal 
integrity or approximal 
contact. 
n.a.
6.3 moderate detectability:  
Major irregularities, ditching 
or flash, steps or minor 
crevice formation 
4. Clinically unsatisfactory / 
(but repairable)   
  
5a.4.1 Material chip 
fractures which damage 
marginal quality or 
approximal contacts 
n.a.
6.4.1 major crevice formation 
6.4.2 Larger irregularities or 
steps (repair necessary) 
5. Clinically poor 
(replacement necessary) 
5a.5multiple fractures
5b.5 Complete Loss 
of restoration 
6.5 Generalized major 
gaps/crevice formation or 
irregularities. 

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PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
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B. Functional properties 
9. Radiographic examination 
(when applicable) 
10. Patient’s view
1. Clinically excellent / very 
good 
9.1 No pathology, harmonious transition 
between restoration and tooth. 
10.1 Entirely satisfied with 
aesthetics and function. 
2. Clinically good
  
9.2.1 Acceptable material excess 
present. 
9.2.2 Positive/negative step present at 
margin <150 µm. 
  
10.2 Satisfied.
10.2.1  Aesthetics. 
10.2.2 Function, e.g., minor 
roughness  
  
B. Functional properties 
7. Occlusal contour and wear
 
 
8. Approximal anatomical form 
a. contact point  
b. contour 
1. Clinically excellent / very good
7.1 No evidence of occlusal wear, 
wear equivalent to enamel 
8a.1 Normal contact point (floss or 25 
µm metal blade can pass) 
8b.1 Normal contour. 
2. Clinically good
  
7.2 Evidence of local facet formation 
< 2.0 mm in diameter, no change in 
occlusal anatomy, wear only slightly 
different from that to enamel 
8a.2. Contact slightly too strong but no 
disadvantage (floss or 25 µm metal 
blade can only pass with pressure). 
8b.2 Slightly deficient contour. 
3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects but not 
adjustable w/o damage) 
7.3 Evidence of local facet formation 
> 2.0 mm in diameter, slight change 
in occlusal anatomy, Different wear 
rate compared to enamel 
8a.3. Somewhat weak contact, no 
indication of damage to tooth, gingiva or 
periodontal structures; 50 µm metal 
blade can pass  
8b.3 Visible deficient contour 
4. Clinically unsatisfactory / (but 
repairable)   
  
7.4 Evidence of generalized facet 
formation with evidence of 
generalized wear altering occlusal 
anatomic form, Wear considerably 
exceeds normal enamel wear 
8a.4 Too weak and possible damage due 
to food impaction;  
100 µm metal blade can pass 
8b.4  Inadequate contour 
Repair possible. 
  
5. Clinically poor 
(replacement necessary) 
7.5 Generalized, excessive occlusal 
wear with loss of anatomic form 
8a.5 Too weak and/or clear damage due 
to food impaction and/or pain/gingivitis.  
8b.4  Insufficient contour requires 
replacement 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects but not 
adjustable w/o damage) 
9. 3. 1 Marginal gap < 250 µm.
9. 3. 2 Negative steps visible < 250 µm. 
No adverse effects noticed. 
9.3.3 Poor radiopacity of the restoration. 
10.3 Minor criticism but no adverse 
clinical effects. 
10.3.1 Aesthetic shortcomings. 
10.3.2 Some lack of chewing 
comfort. 
10.3.3 Unpleasant treatment 
procedure.  
4. Clinically unsatisfactory / 
(but repairable)   
  
9.4.1 Marginal gap >250 µm.
9.4.2 Material excess accessible but not 
removable. 
9.4.3 Negative steps >250µm and 
repairable. 
10.4 Desire for improvement 
10.4.1 Aesthetics. 
10.4.2 Function, e.g., tongue 
irritation  
Reshaping of anatomic form or 
refurbishing is possible. 
5. Clinically poor 
(replacement necessary) 
9.5.1 Secondary caries, large gaps, large 
overhangs 
9.5.2 Apical pathology 
9.5.3 Fracture/loss of restoration or tooth.
10.5 Completely dissatisfied and / 
or adverse effects, incl. pain. 
 
 
 
 
 
C. Biological properties 
11. Postoperative (hyper-) sensitivity 
and tooth vitality  
12. Recurrence of caries (CAR), 
erosion, abfraction 
1. Clinically very good
11.1 No hypersensitivity, normal vitality.
12.1 No secondary or primary caries
2. Clinically good
(after correction maybe very 
good) 
No treatment required. 
11.2 Minor hypersensitivity for a limited 
period of time, normal vitality. 
12.2 Small and localized 
1. Demineralization 
2. Erosion or  
3. Abfraction.  
3.Clinically sufficient / 
satisfactory 
(minor shortcomings with no 
adverse effects but not 
adjustable without damage 
to the tooth) 
11.3.1 Moderate hypersensitivity 
11.3.2 Delayed/mild sensitivity; no 
subjective complaints, no treatment 
needed. 
12.3 Larger areas of 1. 
Demineralisation 
2. Erosion or  
3.Abrasion/abfraction, dentine not 
exposed Only preventive measures 
necessary. 
4. Clinically unsatisfactory
(repair for prophylactic reasons) 
11.4.1 Intense hypersensitivity.
11.4.2 Delayed with minor subjective 
symptoms. 
11.4.3 No clinical detectable sensitivity. 
  
Intervention necessary 
but not replacement. 
12. 4.1 Caries with cavitation and 
suspected undermining caries 
12.4.2 Erosion in dentin 
12.4.3 Abrasion/ abfraction in 
dentin. 
Localized and accessible can be 
repaired. 
5. Clinically poor
(replacement necessary) 
11.5 Intense, acute pulpitis or non-vital 
tooth. Endodontic treatment is 
necessary, and restoration has to be 
replaced. 
12.5 Deep 
caries or exposed dentine that is not 
accessible for repair of restoration. 
 

3M ID# CR 19/03, Version: 1 
 
PI: Dr Dennis Fasbinder 
Clinical Performance of Chairside CAD/CAM Restorations using a New Adhesive Cement 
 
2/24/2025 
 
 
 
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