Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
NCT ID: NCT01268605
Last Updated: 2014-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
341 participants
INTERVENTIONAL
2010-09-30
2012-04-30
Brief Summary
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The primary outcome of this study is the reduction/elimination of restoration POH as measured by clinical assessment (air stream) and patient-reports.
Outcomes will be ascertained via the following specific aims:
Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical measurement (air drying) and by patient-reported outcomes among the two treatment groups at three points in time: prior to restoration and at one and four weeks postrestoration.
Specific Aim 2: To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed American Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Restoration with a dentin bonding agent (DBA)
Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.
Restoration with a dentin bonding agent (DBA)
Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.
Restoration with a resin modified glass ionomer liner (RMGI)
Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
Restoration with a resin modified glass ionomer liner (RMGI)
Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
Interventions
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Restoration with a dentin bonding agent (DBA)
Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.
Restoration with a resin modified glass ionomer liner (RMGI)
Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
Eligibility Criteria
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Inclusion Criteria
3. Lesion depth, if visible on radiograph, must be ≤1/2 the distance from the Dento-Enamel Junction (DEJ) to the pulp and the radiograph cannot be more than 9 months old.
4. The tooth must be in occlusion with a natural tooth.
5. A resin-based composite restoration would be the standard of care for the lesion.
6. The tooth must be free of evidence of a pulpitis (no report of lingering pain associated with any stimulus).
7. Subjects must be available for contact for at least four weeks post-treatment.
8. Subjects willing and able to understand and sign the IRB-approved informed consent form and for individuals under the age of 18, the parental / guardian assent form.
9. Subject's baseline score on the NPAS must be ≥3 for air and/or cold stimulation but not exhibit pain lasting more than approximately four seconds which is known as "lingering pain"
10. Gingival Index of less than or equal to 2.
Exclusion Criteria
2. Teeth with a mobility of 2 or greater, or inflamed gingival tissues.
3. Existing restoration(s) on the same tooth.
4. Teeth that have been clinically assessed to be fractured.
5. Tooth is an abutment for a removable partial denture.
6. Tooth with subgingival calculus, unless removed during the treatment visit.
7. Subjects undergoing active orthodontic treatment. Use of retainers is allowed.
8. Subjects currently enrolled in or who have completed in the past month a tooth bleaching program.
9. Subjects with prior reaction or inability to tolerate any of the dental products being used, such as severe topical or hypersensitivity reaction.
10. Subjects 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 postoperative hypersensitivity and ability to understand the informed consent process.
11. Subjects in another ongoing dental research study.
15 Years
60 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Pearl Network
NETWORK
Responsible Party
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Principal Investigators
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Frederick A Curro, DMD, Phd
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Phoenix Pediatric Dental
Phoeniz, Arizona, United States
Watson and Niven Dental Partnership
Newport Beach, California, United States
Jana A. Ikeda, DDS, PC
Boulder, Colorado, United States
Maryann Lehmann, D.D.S.
Darien, Connecticut, United States
Oracare Research
Sanford, Florida, United States
Complete Dental Arts, P.C.
Newnan, Georgia, United States
Creative Smiles Dental Care
Champaign, Illinois, United States
Peggy Richardson, DDS, MS
Tinley Park, Illinois, United States
Kokomo Oral Implantology
Kokomo, Indiana, United States
Corridor Kids Pediatric Dentistry
North Liberty, Iowa, United States
Community Dental - Biddeford Center
Biddeford, Maine, United States
Cheryl F, Callahan, DDS, PA
Rockville, Maryland, United States
Oral Medicine - Tufts School of Dental Medicine
Boston, Massachusetts, United States
Frank A Dahlstrom,DMD,PC
Dennis, Massachusetts, United States
Oral Health Center
Southborough, Massachusetts, United States
Small Smiles Dental Center of Springfield, LLC
Springfield, Massachusetts, United States
Keith A Hudson DDS PC
Franklin, Michigan, United States
Minnesota Dentalcare
Richfield, Minnesota, United States
Eric Hirschfeld, D.D.S.
Conway, New Hampshire, United States
Bordentown Family Dental
Bordentown, New Jersey, United States
Scott B Schaffer, DMD
Clark, New Jersey, United States
Gentle Dental Care, LLC
Edison, New Jersey, United States
Dr. Howard Spielman
Plainsboro, New Jersey, United States
Barry G. Dale, DMD
Tenafly, New Jersey, United States
Cynthia Jetter, DMD
Voorhees Township, New Jersey, United States
Bay Dental PC
Brooklyn, New York, United States
Eric Leibowitz DDS
Brooklyn, New York, United States
Queens Comprehensive Dental Services
Forest Hills, New York, United States
Gilberto Nunez DDS LLC
Kingston, New York, United States
Kay T. Oen, DDS
Port Chester, New York, United States
East Avenue Dentistry PLLC
Rochester, New York, United States
James R. Keenan, DDS, PC
Rockaway Beach, New York, United States
Janice K. Pliszczak, DDS
Syracuse, New York, United States
Susan D. Bernstein, DDS
Cincinnati, Ohio, United States
Laurence H Stone, DDS
Doylestown, Pennsylvania, United States
Dr. Jeannette Abboud-Niemczyk
Drexel Hill, Pennsylvania, United States
Allan J Horowitz, DMD
King of Prussia, Pennsylvania, United States
Dr. Julie Ann Barna
Lewisburg, Pennsylvania, United States
Salvation Army Dental Center
Oil City, Pennsylvania, United States
Elizabeth W. Galloway
Hilton Head Island, South Carolina, United States
MEHOP
Bay City, Texas, United States
Countries
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References
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American Academy of Sleep Medicine (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine.
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Other Identifiers
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136277
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRL1013
Identifier Type: -
Identifier Source: org_study_id
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