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Sample study

The practice-based model was recently employed in the research study described below. It was an industry-funded project and the effort was highly lauded by the sponsoring company, 3M/ESPE. According to their director of clinical research, the study provided valuable information to the company because it made available “real world” results of how their product could be expected to perform.

A Clinical Comparison of Two Cements for Levels of Post-operative Sensitivity in a Practice-based Setting
T Hilton, D Hilton, R Randall, JL Ferracane
Operative Dentistry, 2004, 29-3, 241-248

Objective:

This study compared the post-operative sequela of cementing full crowns (all metal or PFM) with either a conventional (Fuji I, GC; n=102 crowns) or a resin modified GI luting cement (Rely X, 3M/ESPE; n=107 crowns).

Methods:

Selection of clinicians.Ten dentists who were in private practice participated in the study. The clinicians participated in a two-hour training session to familiarize them with the protocol for the study, and to standardize the procedures and techniques utilized in the study.

Clinical and laboratory procedures. General guidelines regarding tooth preparation were agreed upon, so that there was conformity to the amount of tooth reduction. Ten private practitioners fabricated 209 crowns. At the time of crown cementation, the clinicians opened an envelope containing a number generated from a random-assignment program. This number told the practitioner which of the two cements to use. In other words, the dentist could not choose which cement would be used; they had to use whichever cement was selected at random.

Data acquisition. Patients were contacted by telephone at the following times: 24 hours after luting the permanent crown, one week later, one and three months later. These contacts were performed by a study coordinator provided by OHSU; the practices did not have to perform the follow-up. During those telephone calls, the patient was questioned regarding postoperative temperature and biting sensitivity. All pre- and post-operative sensitivity was patient reported. Data were subjected to statistical analysis.

Results:

50.7% of all patients reported any sensitivity at any time period. Mean sensitivity for all patients, on a 10-point scale, was 0.52 for temperature and 0.23 for biting. Cements did not differ in cold or biting sensitivity at any time point. Rely X showed higher heat sensitivity than Fuji I at 24 hours, but lower heat sensitivity at 3 months. There were many significant (though low) correlations between the sensitivity measures and age (inverse relationship) and dentin area of preparation (direct), i.e. post-cementation sensitivity was inversely related to the patient’s age, and directly related to how much of the preparation consisted of tooth structure (vs. build-up material). Although logical to assume such a result, it had not been previously demonstrated in the literature. Overall, both cements yielded similar sensitivity outcomes.

Conclusions:

Approximately half of the patients experienced any post-operative sensitivity. When sensitivity occurred it was generally of low intensity for both cements.

Combined Mean Sensitivity Values Over Time

Summary and Conclusions

  1. No differences in cold, heat or biting sensitivity over time were found for either cement.
  2. There were no differences in any sensitivity category at any time period between the two cements.
  3. All metal crowns demonstrated greater temperature sensitivity, but not biting sensitivity, compared to PFM crowns.
  4. Age is inversely correlated to all sensitivity measures, and preparation dentin surface area is directly related to all sensitivity measures, but only cold sensitivity is significant.
  5. All metal crowns, younger age and increased preparation dentin surface area are predictors of increased cold sensitivity.
  6. All metal crowns and younger age are predictors of increased heat sensitivity.
  7. Younger age is a predictor of increased biting sensitivity.
  8. Overall sensitivity with either cement was very low.