Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial



Status:Archived
Conditions:Other Indications, Neurology, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Neurology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010

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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.



We found this trial at
16
sites
Rochester, New York 14610
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Rochester, NY
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Bordentown, New Jersey 08505
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Bordentown, NJ
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Brooklyn, New York 11229
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Brooklyn, NY
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Clark, New Jersey 07066
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Clark, NJ
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Darien, Connecticut 06820
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Darien, CT
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Doylestown, Pennsylvania 18902
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Doylestown, PA
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Drexel Hill, Pennsylvania 19026
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Drexel Hill, PA
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Edison, New Jersey 08820
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Edison, NJ
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Forest Hills, New York 11375
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Forest Hills, NY
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King of Prussia, Pennsylvania 19406
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King of Prussia, PA
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Lewisburg, Pennsylvania 17837
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Lewisburg, PA
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Port Chester, New York 10573
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Port Chester, NY
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Sanford, Florida 32771
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Sanford, FL
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Springfield, Massachusetts 01128
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Springfield, MA
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Syracuse, New York 13215
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Syracuse, NY
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Voorhees, New Jersey 08043
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Voorhees, NJ
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