Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial (POH RCERT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Pearl Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pearl Network
ClinicalTrials.gov Identifier:
NCT01268605
First received: October 19, 2010
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Dental Caries
Procedure: Restoration with a dentin bonding agent (DBA)
Procedure: Restoration with a resin modified glass ionomer liner (RMGI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity: Randomized Comparative Effectiveness Research Trial

Resource links provided by NLM:


Further study details as provided by Pearl Network:

Primary Outcome Measures:
  • Hypersensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Preoperative caries stage [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Lesion depth [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Dentin caries activity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Preparation depth [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Sleep bruxism status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 334
Study Start Date: September 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268605

  Show 41 Study Locations
Sponsors and Collaborators
Pearl Network
Investigators
Principal Investigator: Frederick A Curro, DMD, Phd New York University School of Medicine
  More Information

Additional Information:
Publications:
Lavigne GJ, Manzini C, Kato T (2005). Sleep Bruxism. In: Principles and practice of sleep medicine. MH Kryger, T Roth and WC Dement editors. Philadelphia: Elsevier, pp. 946-59

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pearl Network
ClinicalTrials.gov Identifier: NCT01268605     History of Changes
Other Study ID Numbers: PRL1013, U01DE016755, 136277
Study First Received: October 19, 2010
Last Updated: February 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Pearl Network:
Dental caries
Resin based composite
Hypersensitivity
Teeth
Dentistry
Practice-based research network

Additional relevant MeSH terms:
Hypersensitivity
Dental Caries
Immune System Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 18, 2014