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
  2. 1/9/15
Uploaded on:

January 9, 2015

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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

No Instruction available.

  1. StudyEvent: PRL1013: Enrollment Form (ENR)
    1. No Instruction available.
Header Module
Inclusion Criteria
year
Tooth Number With Occlusal Caries
Tooth number with occlusal caries
Tooth quadrant
Air stimulation pain level
Does the pain linger >4 seconds (after removal of air blast)
Cold stimulation pain level
min
Does the pain linger > 4 seconds
Gingival index
Inclusion Criteria
Does the subject have solely adult dentition
Are all protocol teeth permanent posterior teeth and present withthe clinical diagnosis of new Class I caries extending into dentinwith or without radiographic confirmation
Are these the only teeth that meet the eligibility criteria
Are these the only teeth that will be treated (will receive restoration) at this time
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
Tooth Number
Tooth quadrant
Inclusion Criteria (cont.2)
Is/Are the protocol tooth/teeth in occlusion with a natural tooth
Would a resin-based composite restoration be the standard of care for the lesion(s)
Is/Are the protocol tooth/teeth free of evidence of a pulpitis (no report of lingering pain associated with any stimulus)
Is the subject available for contact for at least four weeks post-treatment
Has the subject signed and dated the IRB-approved informed consent form or assent form for individuals under 18 years old
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)
Does/Do the protocol tooth/teeth have existing restoration(s)
Has/Have the protocol tooth/teeth been clinically assessed to be fractured
Is/Are the protocol tooth/teeth an abutment(s) for a removable partial denture
Does/Do the protocol tooth/teeth have subgingival calculus(eligible if removed during the treatment visit)
Is the subject undergoing active orthodontic treatment other than the use of a retainer
Is the subject currently enrolled or have they completed in the past month a tooth bleaching program
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)
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
Is the subject in another ongoing dental research study
Footer Module
Preferred method of contact

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