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.