Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial (POH RCERT)

September 18, 2014 updated by: Pearl Network

Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity: Randomized Comparative Effectiveness Research Trial

Postoperative hypersensitivity (POH) is a problem for many patients as determined by the recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following occlusal caries restoration. The objectives of this two-armed randomized comparative effectiveness research trial (RCERT) are to determine whether adding a resin modified glass ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC) restorations, and to identify other factors (putative risk factors) that are associated with increased POH.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoeniz, Arizona, United States, 85015
        • Phoenix Pediatric Dental
    • California
      • Newport Beach, California, United States, 92660
        • Watson and Niven Dental Partnership
    • Colorado
      • Boulder, Colorado, United States, 80305
        • Jana A. Ikeda, DDS, PC
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Maryann Lehmann, D.D.S.
    • Florida
      • Sanford, Florida, United States, 32771
        • Oracare Research
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Complete Dental Arts, P.C.
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Creative Smiles Dental Care
      • Tinley Park, Illinois, United States, 60477
        • Peggy Richardson, DDS, MS
    • Indiana
      • Kokomo, Indiana, United States, 46901
        • Kokomo Oral Implantology
    • Iowa
      • North Liberty, Iowa, United States, 52317
        • Corridor Kids Pediatric Dentistry
    • Maine
      • Biddeford, Maine, United States, 04005
        • Community Dental - Biddeford Center
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Cheryl F, Callahan, DDS, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Oral Medicine - Tufts School of Dental Medicine
      • Dennis, Massachusetts, United States, 02638
        • Frank A Dahlstrom,DMD,PC
      • Southborough, Massachusetts, United States, 01772
        • Oral Health Center
      • Springfield, Massachusetts, United States, 01128
        • Small Smiles Dental Center of Springfield, LLC
    • Michigan
      • Franklin, Michigan, United States, 48025
        • Keith A Hudson DDS PC
    • Minnesota
      • Richfield, Minnesota, United States, 55423
        • Minnesota Dentalcare
    • New Hampshire
      • Conway, New Hampshire, United States, 03818
        • Eric Hirschfeld, D.D.S.
    • New Jersey
      • Bordentown, New Jersey, United States, 08505
        • Bordentown Family Dental
      • Clark, New Jersey, United States, 07066
        • Scott B Schaffer, DMD
      • Edison, New Jersey, United States, 08820
        • Gentle Dental Care, LLC
      • Plainsboro, New Jersey, United States, 08536
        • Dr. Howard Spielman
      • Tenafly, New Jersey, United States, 07670
        • Barry G. Dale, DMD
      • Voorhees, New Jersey, United States, 08043
        • Cynthia Jetter, DMD
    • New York
      • Brooklyn, New York, United States, 11229
        • Bay Dental PC
      • Brooklyn, New York, United States, 11230
        • Eric Leibowitz DDS
      • Forest Hills, New York, United States, 11375
        • Queens Comprehensive Dental Services
      • Kingston, New York, United States, 12401
        • Gilberto Nunez DDS LLC
      • Port Chester, New York, United States, 10573
        • Kay T. Oen, DDS
      • Rochester, New York, United States, 14610
        • East Avenue Dentistry PLLC
      • Rockaway Beach, New York, United States, 11693
        • James R. Keenan, DDS, PC
      • Syracuse, New York, United States, 13215
        • Janice K. Pliszczak, DDS
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Susan D. Bernstein, DDS
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18902
        • Laurence H Stone, DDS
      • Drexel Hill, Pennsylvania, United States, 19026
        • Dr. Jeannette Abboud-Niemczyk
      • King of Prussia, Pennsylvania, United States, 19406
        • Allan J Horowitz, DMD
      • Lewisburg, Pennsylvania, United States, 17837
        • Dr. Julie Ann Barna
      • Oil City, Pennsylvania, United States, 16301
        • Salvation Army Dental Center
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29928
        • Elizabeth W. Galloway
    • Texas
      • Bay City, Texas, United States, 77414
        • MEHOP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Presence of solely adult dentition ages 15 to 60 (The upper age of 60 years is selected since the pulp space is limited and POH is less likely above this age).
  2. Presence of one or more permanent posterior teeth (in different quadrants, with third molars excluded) with the clinical diagnosis of new Class I caries extending into dentin with or without radiographic confirmation. Up to 4 teeth (one per quadrant) may be enrolled. If there is more than one occlusal lesion in a quadrant that meets the inclusion criteria the patient is not eligible for inclusion in the study. Only one tooth per quadrant can be treated during the 4 weeks of this study.
  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:

  1. Individuals in which the second molars are not fully erupted.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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).
Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypersensitivity
Time Frame: 4 weeks
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative caries stage
Time Frame: Baseline
To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.
Baseline
Lesion depth
Time Frame: Baseline
To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.
Baseline
Dentin caries activity
Time Frame: Baseline
To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.
Baseline
Preparation depth
Time Frame: Baseline
To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.
Baseline
Sleep bruxism status
Time Frame: Baseline
To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pearl Network

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Frederick A Curro, DMD, PhD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRL1013
  • U01DE016755 (U.S. NIH Grant/Contract)
  • 136277 (Other Grant/Funding Number: NIDCR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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