ID

8682

Description

PRL1013: Enrollment Form (ENR) Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial (POH RCERT) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A63D65F7-CD34-5822-E040-BB89AD4372DF

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A63D65F7-CD34-5822-E040-BB89AD4372DF

Keywords

Versions (2)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Dental Caries NCT01268605 Eligibility - PRL1013: Enrollment Form (ENR) - 3246000v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: PRL1013: Enrollment Form (ENR)
    1. No Instruction available.
Header Module
Description

Header Module

Site Code
Description

PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus ObjectClass-2
C37901
UMLS 2011AA ObjectClass-2
C0205145
NCI Thesaurus ObjectClass-3
C52664
UMLS 2011AA ObjectClass-3
C1709628
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Date of visit
Description

PatientDentistVisitDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C52654
UMLS 2011AA Property
C0011441
NCI Thesaurus Property-2
C25716
UMLS 2011AA Property-2
C0545082
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Subject ID
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Subject Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Inclusion Criteria
Description

Inclusion Criteria

Subject's age
Description

PersonReportedAgeValue

Data type

float

Measurement units
  • year
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property-2
C25150
UMLS 2011AA Property-2
C0001779
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
year
How many teeth are being enrolled on this protocol
Description

ToothClinicalTrialEnrollmentNumber

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C15207
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property-2
C37948
UMLS 2011AA Property
C1516879
Tooth Number With Occlusal Caries
Description

Tooth Number With Occlusal Caries

Tooth number with occlusal caries
Description

OcclusalSurfaceCariesPresentDentitionCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C52593
UMLS 2011AA ObjectClass
C0011334
NCI Thesaurus ObjectClass-2
C52591
UMLS 2011AA ObjectClass-2
C0447303
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ValueDomain-2
C13072
UMLS 2011AA ValueDomain-2
C0011443
Tooth quadrant
Description

ToothMouthQuadrantAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C12421
UMLS 2011AA Property-2
C0226896
NCI Thesaurus Property-3
C61106
UMLS 2011AA Property-3
C1631280
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Air velocity
Description

DentalInstrumentationAirSpeedDescriptionValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C41136
UMLS 2011AA ObjectClass
C0226984
NCI Thesaurus ObjectClass-2
C16742
UMLS 2011AA ObjectClass-2
C0348000
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus Property-2
C41146
UMLS 2011AA Property-2
C0678536
NCI Metathesaurus Property
C0001861
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Air stimulation pain level
Description

ToothSensitivityAirStimulationAssessmentScale

Data type

text

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus ObjectClass-2
C25201
UMLS 2011AA ObjectClass-2
C1522640
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C61406
UMLS 2011AA Property
C1948023
NCI Thesaurus Property-3
C73434
UMLS 2011AA Property-2
C0001861
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Does the pain linger >4 seconds (after removal of air blast)
Description

ToothRemainingColdSensitivityAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C25201
UMLS 2011AA Property
C1522640
NCI Thesaurus Property-3
C25649
UMLS 2011AA Property-2
C1527428
NCI Thesaurus Property-4
C62180
UMLS 2011AA Property-3
C0009264
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Cold stimulation pain level
Description

ToothSensitivityColdAssessmentScale

Data type

text

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus ObjectClass-2
C25201
UMLS 2011AA ObjectClass-2
C1522640
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C62180
UMLS 2011AA Property
C0009264
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Time to cold sensation
Description

ToothColdSensitivityAssessmentDuration

Data type

float

Measurement units
  • min
Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C25201
UMLS 2011AA Property
C1522640
NCI Thesaurus Property-3
C62180
UMLS 2011AA Property-2
C0009264
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
min
Does the pain linger > 4 seconds
Description

ToothRemainingHotSensitivityAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C25201
UMLS 2011AA Property
C1522640
NCI Thesaurus Property-3
C25649
UMLS 2011AA Property-2
C1527428
NCI Thesaurus Property-4
C62181
UMLS 2011AA Property-3
C2350229
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Gingival index
Description

GingivaAssessmentScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C32677
UMLS 2011AA ObjectClass
C0017562
Inclusion Criteria
Description

Inclusion Criteria

Does the subject have solely adult dentition
Description

PermanentToothDentitionAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C13072
UMLS 2011AA ObjectClass
C0011443
NCI Thesaurus ObjectClass-2
C33313
UMLS 2011AA ObjectClass-2
C0348070
Are all protocol teeth permanent posterior teeth and present withthe clinical diagnosis of new Class I caries extending into dentinwith or without radiographic confirmation
Description

PermanentToothCariesPresentInd-4

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Metathesaurus ObjectClass
C0205355
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C52593
UMLS 2011AA Property-2
C0011334
NCI Metathesaurus ValueDomain
CL356172
Are these the only teeth that meet the eligibility criteria
Description

ClinicalStudyNoOtherToothEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C49487
UMLS 2011AA ObjectClass-2
C1298908
NCI Thesaurus ObjectClass-3
C15206
UMLS 2011AA ObjectClass-3
C0008972
NCI Thesaurus ObjectClass-4
C12506
UMLS 2011AA ObjectClass-4
C0040426
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Are these the only teeth that will be treated (will receive restoration) at this time
Description

PersonToothIncludeClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12506
UMLS 2011AA Property
C0040426
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C74521
UMLS 2011AA Property-3
C2700399
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Inclusion Criteria (cont.1)
Description

Inclusion Criteria (cont.1)

Is/Are the radiographic depth(s) of the lesion(s), when visible, less than or equal to half the Dento-Enamel Junction (DEJ) to the pulp
Description

ToothLesionDentinEnamelConjunctionRelationshipPhysicalExaminationIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C12506
UMLS 2011AA ObjectClass-2
C0040426
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property-2
C0439849
NCI Thesaurus Property-3
C79874
UMLS 2011AA Property-3
C2699427
NCI Thesaurus Property-4
C32453
UMLS 2011AA Property-4
C0011429
NCI Thesaurus Property-5
C32505
UMLS 2011AA Property-5
C0011350
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Tooth Number
Description

DentitionNumberSystemNationalDentitionCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C13072
UMLS 2011AA ObjectClass
C0011443
NCI Thesaurus Property
C25337
UMLS 2011AA Property
C0237753
NCI Thesaurus Property-2
C25700
UMLS 2011AA Property-2
C0449913
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ValueDomain-2
C13072
UMLS 2011AA ValueDomain-2
C0011443
Tooth quadrant
Description

ToothMouthQuadrantAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C12421
UMLS 2011AA Property-2
C0226896
NCI Thesaurus Property-3
C61106
UMLS 2011AA Property-3
C1631280
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
What was the date of theradiograph (If yes, - Referring Question is in prior Module Is/Are the radiographic depths of the lesions, when visible, less than or equal to half the Dento-Enamel Junction DEJ to the pulp?)
Description

BitewingRadiographDiagnosticImagingAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C62057
UMLS 2011AA ObjectClass-2
C1879851
Inclusion Criteria (cont.2)
Description

Inclusion Criteria (cont.2)

Is/Are the protocol tooth/teeth in occlusion with a natural tooth
Description

ToothNaturalPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property-2
C85060
UMLS 2011AA Property-2
C0205296
Would a resin-based composite restoration be the standard of care for the lesion(s)
Description

Resin-BasedCompositeTherapyStandardPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C52586
UMLS 2011AA ObjectClass
C1711229
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C44275
UMLS 2011AA Property-2
C1442989
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is/Are the protocol tooth/teeth free of evidence of a pulpitis (no report of lingering pain associated with any stimulus)
Description

ToothNoPulpitisPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C49487
UMLS 2011AA Property-2
C1298908
NCI Thesaurus Property-3
C52595
UMLS 2011AA Property-3
C0034103
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the subject available for contact for at least four weeks post-treatment
Description

PatientFutureFollow-upInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
Has the subject signed and dated the IRB-approved informed consent form or assent form for individuals under 18 years old
Description

ConsentFormPatientResponsiblePersonSignedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25657
UMLS 2011AA Property-2
C1273518
NCI Thesaurus Property-3
C25679
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of signed, witnessed, and dated informed consent/assent
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Exclusion Criteria (all Responses Must Be Checked "no" To Be Eligible)
Description

Exclusion Criteria (all Responses Must Be Checked "no" To Be Eligible)

Is/Are the protocol tooth/teeth periodontally involved (mobility of 2 or greater or inflamed gingival tissues)
Description

PatientPeriodontalDisorderDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C63743
UMLS 2011AA Property-2
C0031090
Does/Do the protocol tooth/teeth have existing restoration(s)
Description

DentalRestorationPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C60718
UMLS 2011AA ObjectClass
C0399059
Has/Have the protocol tooth/teeth been clinically assessed to be fractured
Description

ToothCrackFracturePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C52648
UMLS 2011AA Property-2
C1706353
NCI Thesaurus Property-3
C50777
UMLS 2011AA Property-3
C0040441
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is/Are the protocol tooth/teeth an abutment(s) for a removable partial denture
Description

AbutmentPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C66853
UMLS 2011AA ObjectClass
C0545406
Does/Do the protocol tooth/teeth have subgingival calculus(eligible if removed during the treatment visit)
Description

DentalProfessionalPracticeDentalCalculusPeriodontiumDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41136
UMLS 2011AA ObjectClass
C0226984
NCI Thesaurus ObjectClass-2
C52673
UMLS 2011AA ObjectClass-2
C0033284
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C60715
UMLS 2011AA Property-2
C0011330
NCI Thesaurus Property-3
C33304
UMLS 2011AA Property-3
C0031093
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the subject undergoing active orthodontic treatment other than the use of a retainer
Description

IntraoralApplianceOrthodonticTreatmentPatientUseInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C64248
UMLS 2011AA ObjectClass-2
C0204193
NCI Thesaurus ObjectClass-3
C62543
UMLS 2011AA ObjectClass-3
C0441330
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the subject currently enrolled or have they completed in the past month a tooth bleaching program
Description

DentalWhiteningUseInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C94591
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Has the subject had a prior reaction or have an inability to tolerate any of the dental products being used (such as severe topical or hypersensitivity reaction)
Description

PersonClinicalStudyAgentHypersensitivityExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the subject under treatment for medical disorders including dementia, Parkinson's disease, severe depression, severe anxiety, and any other medical condition that, in the opinion of the P-I, would affect the subject's judgment of post-operative hypersensitivity and/or ability to understand the informed consent process
Description

PatientPre-existingConditionImpairmentConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C54056
UMLS 2011AA Property
C0521987
NCI Thesaurus Property-2
C21055
UMLS 2011AA Property-2
C0684336
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the subject in another ongoing dental research study
Description

PatientOtherDentalClinicalStudyEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C41136
UMLS 2011AA Property-2
C0226984
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C37948
UMLS 2011AA Property-4
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Footer Module
Description

Footer Module

Preferred method of contact
Description

PatientContactPreferredMethodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus Property-2
C42711
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: PRL1013: Enrollment Form (ENR)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber
Item
Site Code
text
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass-2)
C0205145 (UMLS 2011AA ObjectClass-2)
C52664 (NCI Thesaurus ObjectClass-3)
C1709628 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PatientDentistVisitDate
Item
Date of visit
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C52654 (NCI Thesaurus Property)
C0011441 (UMLS 2011AA Property)
C25716 (NCI Thesaurus Property-2)
C0545082 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Patient Study ID
Item
Subject ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Subject Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Inclusion Criteria
PersonReportedAgeValue
Item
Subject's age
float
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ToothClinicalTrialEnrollmentNumber
Item
How many teeth are being enrolled on this protocol
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus Property)
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property)
Item Group
Tooth Number With Occlusal Caries
Item
Tooth number with occlusal caries
text
C52593 (NCI Thesaurus ObjectClass)
C0011334 (UMLS 2011AA ObjectClass)
C52591 (NCI Thesaurus ObjectClass-2)
C0447303 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C13072 (NCI Thesaurus ValueDomain-2)
C0011443 (UMLS 2011AA ValueDomain-2)
CL.2
Code List
Tooth number with occlusal caries
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Upper Left (12)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Upper Left (13)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Upper Left (14)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Upper Left (15)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Lower Left (18)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Lower Left (19)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Upper Right (2)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Lower Left (20)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Lower Left (21)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Lower Right (28)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Lower Right (29)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Upper Right (3)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Lower Right (30)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Lower Right (31)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Upper Right (4)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Upper Right (5)
Item
Tooth quadrant
text
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12421 (NCI Thesaurus Property-2)
C0226896 (UMLS 2011AA Property-2)
C61106 (NCI Thesaurus Property-3)
C1631280 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.15
Code List
Tooth quadrant
CL Item
Upper Right Quadrant (Upper Right)
CL Item
Upper Left Quadrant (Upper Left)
CL Item
Lower Right Quadrant (Lower Right)
CL Item
Lower Left Quadrant (Lower Left)
DentalInstrumentationAirSpeedDescriptionValue
Item
Air velocity
float
C41136 (NCI Thesaurus ObjectClass)
C0226984 (UMLS 2011AA ObjectClass)
C16742 (NCI Thesaurus ObjectClass-2)
C0348000 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C41146 (NCI Thesaurus Property-2)
C0678536 (UMLS 2011AA Property-2)
C0001861 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Air stimulation pain level
text
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25201 (NCI Thesaurus ObjectClass-2)
C1522640 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C61406 (NCI Thesaurus Property-2)
C1948023 (UMLS 2011AA Property)
C73434 (NCI Thesaurus Property-3)
C0001861 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL.4
Code List
Air stimulation pain level
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
ToothRemainingColdSensitivityAssessmentInd-2
Item
Does the pain linger >4 seconds (after removal of air blast)
boolean
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25201 (NCI Thesaurus Property-2)
C1522640 (UMLS 2011AA Property)
C25649 (NCI Thesaurus Property-3)
C1527428 (UMLS 2011AA Property-2)
C62180 (NCI Thesaurus Property-4)
C0009264 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Cold stimulation pain level
text
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25201 (NCI Thesaurus ObjectClass-2)
C1522640 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C62180 (NCI Thesaurus Property-2)
C0009264 (UMLS 2011AA Property)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL.6
Code List
Cold stimulation pain level
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
ToothColdSensitivityAssessmentDuration
Item
Time to cold sensation
float
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25201 (NCI Thesaurus Property-2)
C1522640 (UMLS 2011AA Property)
C62180 (NCI Thesaurus Property-3)
C0009264 (UMLS 2011AA Property-2)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
ToothRemainingHotSensitivityAssessmentInd-2
Item
Does the pain linger > 4 seconds
boolean
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25201 (NCI Thesaurus Property-2)
C1522640 (UMLS 2011AA Property)
C25649 (NCI Thesaurus Property-3)
C1527428 (UMLS 2011AA Property-2)
C62181 (NCI Thesaurus Property-4)
C2350229 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Gingival index
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C32677 (NCI Thesaurus ObjectClass)
C0017562 (UMLS 2011AA ObjectClass)
CL.8
Code List
Gingival index
CL Item
Normal Appearance, No Bleeding (Normal appearance, no bleeding)
CL Item
Mild Inflammation; Slight Change In Color And Mild Edema (Mild inflammation; slight change in color and mild edema)
CL Item
Moderate Inflammation; Redness, Edema And Glazing; Bleeding On Probing (Moderate inflammation; redness, edema and glazing; bleeding on probing)
CL Item
Severe Inflammation; Marked Redness And Edema; Ulceration; Spontaneous Bleeding (Severe inflammation; marked redness and edema; ulceration; spontaneous bleeding)
Item Group
Inclusion Criteria
PermanentToothDentitionAssessmentInd-2
Item
Does the subject have solely adult dentition
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C13072 (NCI Thesaurus ObjectClass)
C0011443 (UMLS 2011AA ObjectClass)
C33313 (NCI Thesaurus ObjectClass-2)
C0348070 (UMLS 2011AA ObjectClass-2)
PermanentToothCariesPresentInd-4
Item
Are all protocol teeth permanent posterior teeth and present withthe clinical diagnosis of new Class I caries extending into dentinwith or without radiographic confirmation
boolean
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C0205355 (NCI Metathesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C52593 (NCI Thesaurus Property-2)
C0011334 (UMLS 2011AA Property-2)
CL356172 (NCI Metathesaurus ValueDomain)
ClinicalStudyNoOtherToothEligibilityDeterminationInd-2
Item
Are these the only teeth that meet the eligibility criteria
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus ObjectClass-2)
C1298908 (UMLS 2011AA ObjectClass-2)
C15206 (NCI Thesaurus ObjectClass-3)
C0008972 (UMLS 2011AA ObjectClass-3)
C12506 (NCI Thesaurus ObjectClass-4)
C0040426 (UMLS 2011AA ObjectClass-4)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonToothIncludeClinicalTrialEligibilityCriteriaInd-2
Item
Are these the only teeth that will be treated (will receive restoration) at this time
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12506 (NCI Thesaurus Property)
C0040426 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C74521 (NCI Thesaurus Property-3)
C2700399 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Inclusion Criteria (cont.1)
Item
Is/Are the radiographic depth(s) of the lesion(s), when visible, less than or equal to half the Dento-Enamel Junction (DEJ) to the pulp
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C12506 (NCI Thesaurus ObjectClass-2)
C0040426 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property-2)
C79874 (NCI Thesaurus Property-3)
C2699427 (UMLS 2011AA Property-3)
C32453 (NCI Thesaurus Property-4)
C0011429 (UMLS 2011AA Property-4)
C32505 (NCI Thesaurus Property-5)
C0011350 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.13
Code List
Is/Are the radiographic depth(s) of the lesion(s), when visible, less than or equal to half the Dento-Enamel Junction (DEJ) to the pulp
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
CL Item
Not Visible, But Confirmed Clinically (Not visible, but confirmed clinically)
Item
Tooth Number
text
C13072 (NCI Thesaurus ObjectClass)
C0011443 (UMLS 2011AA ObjectClass)
C25337 (NCI Thesaurus Property)
C0237753 (UMLS 2011AA Property)
C25700 (NCI Thesaurus Property-2)
C0449913 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C13072 (NCI Thesaurus ValueDomain-2)
C0011443 (UMLS 2011AA ValueDomain-2)
CL.14
Code List
Tooth Number
CL Item
3rd Molar (wisdom Tooth) Permanent Arch Upper Right (1)
CL Item
Lateral Incisor Permanent Arch Upper Left (10)
CL Item
Cuspid (canine/eye Tooth) Permanent Arch Upper Left (11)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Upper Left (12)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Upper Left (13)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Upper Left (14)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Upper Left (15)
CL Item
3rd Molar (wisdom Tooth) Permanent Arch Upper Left (16)
CL Item
3rd Molar (wisdom Tooth) Permanent Arch Lower Left (17)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Lower Left (18)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Lower Left (19)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Upper Right (2)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Lower Left (20)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Lower Left (21)
CL Item
Cuspid (canine/eye Tooth) Permanent Arch Lower Left (22)
CL Item
Lateral Incisor Permanent Arch Lower Left (23)
CL Item
Central Incisor Permanent Arch Lower Left (24)
CL Item
Central Incisor Permanent Arch Lower Right (25)
CL Item
Lateral Incisor Permanent Arch Lower Right (26)
CL Item
Cuspid (canine/eye Tooth) Permanent Arch Lower Right (27)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Lower Right (28)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Lower Right (29)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Upper Right (3)
CL Item
1st Molar (6-yr. Molar) Permanent Arch Lower Right (30)
CL Item
2nd Molar (12-yr. Molar) Permanent Arch Lower Right (31)
CL Item
3rd Molar (wisdom Tooth) Permanent Arch Lower Right (32)
CL Item
2nd Bicuspid (2nd Premolar) Permanent Arch Upper Right (4)
CL Item
1st Bicuspid (1st Premolar) Permanent Arch Upper Right (5)
CL Item
Supernumerary 3rd Molar (wisdom Tooth) Permanent Arch Upper Right (51)
CL Item
Supernumerary 2nd Molar (12-yr. Molar) Permanent Arch Upper Right (52)
CL Item
Supernumerary 1st Molar (6-yr. Molar) Permanent Arch Upper Right (53)
CL Item
Supernumerary 2nd Bicuspid (2nd Premolar) Permanent Arch Upper Right (54)
CL Item
Supernumerary 1st Bicuspid (1st Premolar) Permanent Arch Upper Right (55)
CL Item
Supernumerary Cuspid (canine/eye Tooth) Permanent Arch Upper Right (56)
CL Item
Supernumerary Lateral Incisor Permanent Arch Upper Right (57)
CL Item
Supernumerary Central Incisor Permanent Arch Upper Right (58)
CL Item
Supernumerary Central Incisor Permanent Arch Upper Left (59)
CL Item
Cuspid (canine/eye Tooth) Permanent Arch Upper Right (6)
CL Item
Supernumerary Lateral Incisor Permanent Arch Upper Left (60)
CL Item
Supernumerary Cuspid (canine/eye Tooth) Permanent Arch Upper Left (61)
CL Item
Supernumerary 1st Bicuspid (1st Premolar) Permanent Arch Upper Left (62)
CL Item
Supernumerary 2nd Bicuspid (2nd Premolar) Permanent Arch Upper Left (63)
CL Item
Supernumerary 1st Molar (6-yr. Molar) Permanent Arch Upper Left (64)
CL Item
Supernumerary 2nd Molar (12-yr. Molar) Permanent Arch Upper Left (65)
CL Item
Supernumerary 3rd Molar (wisdom Tooth) Permanent Arch Upper Left (66)
CL Item
Supernumerary 3rd Molar (wisdom Tooth) Permanent Arch Lower Left (67)
CL Item
Supernumerary 2nd Molar (12-yr. Molar) Permanent Arch Lower Left (68)
CL Item
Supernumerary 1st Molar (6-yr. Molar) Permanent Arch Lower Left (69)
CL Item
Lateral Incisor Permanent Arch Upper Right (7)
CL Item
Supernumerary 2nd Bicuspid (2nd Premolar) Permanent Arch Lower Left (70)
CL Item
Supernumerary 1st Bicuspid (1st Premolar) Permanent Arch Lower Left (71)
CL Item
Supernumerary Cuspid (canine/eye Tooth) Permanent Arch Lower Left (72)
CL Item
Supernumerary Lateral Incisor Permanent Arch Lower Left (73)
CL Item
Supernumerary Central Incisor Permanent Arch Lower Left (74)
CL Item
Supernumerary Central Incisor Permanent Arch Lower Right (75)
CL Item
Supernumerary Lateral Incisor Permanent Arch Lower Right (76)
CL Item
Supernumerary Cuspid (canine/eye Tooth) Permanent Arch Lower Right (77)
CL Item
Supernumerary 1st Bicuspid (1st Premolar) Permanent Arch Lower Right (78)
CL Item
Supernumerary 2nd Bicuspid (2nd Premolar) Permanent Arch Lower Right (79)
CL Item
Central Incisor Permanent Arch Upper Right (8)
CL Item
Supernumerary 1st Molar (6-yr. Molar) Permanent Arch Lower Right (80)
CL Item
Supernumerary 2nd Molar (12-yr. Molar) Permanent Arch Lower Right (81)
CL Item
Supernumerary 3rd Molar (wisdom Tooth) Permanent Arch Lower Right (82)
CL Item
Central Incisor Permanent Arch Upper Left (9)
CL Item
Second Molar Primary Arch Upper Right (A)
CL Item
Supernumerary Second Molar Primary Arch Upper Right (AS)
CL Item
First Molar Primary Arch Upper Right (B)
CL Item
Supernumerary First Molar Primary Arch Upper Right (BS)
CL Item
Canine(cuspid) Primary Arch Upper Right (C)
CL Item
Supernumerary Canine(cuspid) Primary Arch Upper Right (CS)
CL Item
Lateral Incisor Primary Arch Upper Right (D)
CL Item
Supernumerary Lateral Incisor Primary Arch Upper Right (DS)
CL Item
Central Incisor Primary Arch Upper Right (E)
CL Item
Supernumerary Central Incisor Primary Arch Upper Right (ES)
CL Item
Central Incisor Primary Arch Upper Left (F)
CL Item
Supernumerary Central Incisor Primary Arch Upper Left (FS)
CL Item
Lateral Incisor Primary Arch Upper Left (G)
CL Item
Supernumerary Lateral Incisor Primary Arch Upper Left (GS)
CL Item
Canine (cuspid) Primary Arch Upper Left (H)
CL Item
Supernumerary Canine (cuspid) Primary Arch Upper Left (HS)
CL Item
First Molar Primary Arch Upper Left (I)
CL Item
Supernumerary First Molar Primary Arch Upper Left (IS)
CL Item
Second Molar Primary Arch Upper Left (J)
CL Item
Supernumerary Second Molar Primary Arch Upper Left (JS)
CL Item
Second Molar Primary Arch Lower Left (K)
CL Item
Supernumerary Second Molar Primary Arch Lower Left (KS)
CL Item
First Molar Primary Arch Lower Left (L)
CL Item
Supernumerary First Molar Primary Arch Lower Left (LS)
CL Item
Canine (cuspid) Primary Arch Lower Left (M)
CL Item
Supernumerary Canine (cuspid) Primary Arch Lower Left (MS)
CL Item
Lateral Incisor Primary Arch Lower Left (N)
CL Item
Supernumerary Lateral Incisor Primary Arch Lower Left (NS)
CL Item
Central Incisor Primary Arch Lower Left (O)
CL Item
Supernumerary Central Incisor Primary Arch Lower Left (OS)
CL Item
Central Incisor Primary Arch Lower Right (P)
CL Item
Supernumerary Central Incisor Primary Arch Lower Right (PS)
CL Item
Lateral Incisor Primary Arch Lower Right (Q)
CL Item
Supernumerary Lateral Incisor Primary Arch Lower Right (QS)
CL Item
Canine (cuspid) Primary Arch Lower Right (R)
CL Item
Supernumerary Canine (cuspid) Primary Arch Lower Right (RS)
CL Item
First Molar Primary Arch Lower Right (S)
CL Item
Supernumerary First Molar Primary Arch Lower Right (SS)
CL Item
Second Molar Primary Arch Lower Right (T)
CL Item
Supernumerary Second Molar Primary Arch Lower Right (TS)
Item
Tooth quadrant
text
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12421 (NCI Thesaurus Property-2)
C0226896 (UMLS 2011AA Property-2)
C61106 (NCI Thesaurus Property-3)
C1631280 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.15
Code List
Tooth quadrant
CL Item
Upper Right Quadrant (Upper Right)
CL Item
Upper Left Quadrant (Upper Left)
CL Item
Lower Right Quadrant (Lower Right)
CL Item
Lower Left Quadrant (Lower Left)
BitewingRadiographDiagnosticImagingAssessmentDate
Item
What was the date of theradiograph (If yes, - Referring Question is in prior Module Is/Are the radiographic depths of the lesions, when visible, less than or equal to half the Dento-Enamel Junction DEJ to the pulp?)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C62057 (NCI Thesaurus ObjectClass-2)
C1879851 (UMLS 2011AA ObjectClass-2)
Item Group
Inclusion Criteria (cont.2)
ToothNaturalPresentInd-2
Item
Is/Are the protocol tooth/teeth in occlusion with a natural tooth
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C85060 (NCI Thesaurus Property-2)
C0205296 (UMLS 2011AA Property-2)
Resin-BasedCompositeTherapyStandardPerformedInd-2
Item
Would a resin-based composite restoration be the standard of care for the lesion(s)
boolean
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass-2)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C44275 (NCI Thesaurus Property-2)
C1442989 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ToothNoPulpitisPresentInd-2
Item
Is/Are the protocol tooth/teeth free of evidence of a pulpitis (no report of lingering pain associated with any stimulus)
boolean
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C49487 (NCI Thesaurus Property-2)
C1298908 (UMLS 2011AA Property-2)
C52595 (NCI Thesaurus Property-3)
C0034103 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientFutureFollow-upInd-2
Item
Is the subject available for contact for at least four weeks post-treatment
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
ConsentFormPatientResponsiblePersonSignedInd-2
Item
Has the subject signed and dated the IRB-approved informed consent form or assent form for individuals under 18 years old
boolean
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25657 (NCI Thesaurus Property-2)
C1273518 (UMLS 2011AA Property-2)
C25679 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
InformedConsentFormSignedDate
Item
Date of signed, witnessed, and dated informed consent/assent
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item Group
Exclusion Criteria (all Responses Must Be Checked "no" To Be Eligible)
PatientPeriodontalDisorderDiagnosisInd-3
Item
Is/Are the protocol tooth/teeth periodontally involved (mobility of 2 or greater or inflamed gingival tissues)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C63743 (NCI Thesaurus Property-2)
C0031090 (UMLS 2011AA Property-2)
DentalRestorationPresentInd-2
Item
Does/Do the protocol tooth/teeth have existing restoration(s)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C60718 (NCI Thesaurus ObjectClass)
C0399059 (UMLS 2011AA ObjectClass)
ToothCrackFracturePresentInd-2
Item
Has/Have the protocol tooth/teeth been clinically assessed to be fractured
boolean
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C52648 (NCI Thesaurus Property-2)
C1706353 (UMLS 2011AA Property-2)
C50777 (NCI Thesaurus Property-3)
C0040441 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AbutmentPresentInd-2
Item
Is/Are the protocol tooth/teeth an abutment(s) for a removable partial denture
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66853 (NCI Thesaurus ObjectClass)
C0545406 (UMLS 2011AA ObjectClass)
DentalProfessionalPracticeDentalCalculusPeriodontiumDiagnosisInd-2
Item
Does/Do the protocol tooth/teeth have subgingival calculus(eligible if removed during the treatment visit)
boolean
C41136 (NCI Thesaurus ObjectClass)
C0226984 (UMLS 2011AA ObjectClass)
C52673 (NCI Thesaurus ObjectClass-2)
C0033284 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C60715 (NCI Thesaurus Property-2)
C0011330 (UMLS 2011AA Property-2)
C33304 (NCI Thesaurus Property-3)
C0031093 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntraoralApplianceOrthodonticTreatmentPatientUseInd-2
Item
Is the subject undergoing active orthodontic treatment other than the use of a retainer
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C64248 (NCI Thesaurus ObjectClass-2)
C0204193 (UMLS 2011AA ObjectClass-2)
C62543 (NCI Thesaurus ObjectClass-3)
C0441330 (UMLS 2011AA ObjectClass-3)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DentalWhiteningUseInd-2
Item
Is the subject currently enrolled or have they completed in the past month a tooth bleaching program
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C94591 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
PersonClinicalStudyAgentHypersensitivityExclusionCriteriaInd-2
Item
Has the subject had a prior reaction or have an inability to tolerate any of the dental products being used (such as severe topical or hypersensitivity reaction)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPre-existingConditionImpairmentConsentInd-2
Item
Is the subject under treatment for medical disorders including dementia, Parkinson's disease, severe depression, severe anxiety, and any other medical condition that, in the opinion of the P-I, would affect the subject's judgment of post-operative hypersensitivity and/or ability to understand the informed consent process
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C54056 (NCI Thesaurus Property)
C0521987 (UMLS 2011AA Property)
C21055 (NCI Thesaurus Property-2)
C0684336 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientOtherDentalClinicalStudyEnrollmentInd-2
Item
Is the subject in another ongoing dental research study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C41136 (NCI Thesaurus Property-2)
C0226984 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C37948 (NCI Thesaurus Property-4)
C1516879 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
Item
Preferred method of contact
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C42711 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.31
Code List
Preferred method of contact
CL Item
E-mail (E-mail)
C25170 (NCI Thesaurus)
C0013849 (UMLS 2011AA)
CL Item
Telephone (Phone)
C25395 (NCI Thesaurus)
C0039457 (UMLS 2011AA)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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