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A Randomised Controlled Trial of Postoperative Sensitivity after Class II Restoration with Bulk-Fill vs Conventional
J Twigg1,2, N Vaid3, A Chavda4
1NIHR Academic Clinical Lecturer, School of Dentistry, University of Leeds, Leeds, UK.
Introduction:
Bulk-fill composites may simplify posterior restorations, saving time and reducing technical complexity. Post-operative sensitivity is a risk of posterior composites; bulk-fill composites could mitigate this. This single centre, double-blinded, parallel groups randomised controlled trial compared postoperative sensitivity following restoration of class II carious lesions with bulk-fill or conventional, layered composite.
Null Hypothesis:
there will be no difference in post-operative sensitivity between the two materials.
Methods:
Participants requiring class II restoration of posterior teeth were randomised to bulk-fill (FU) (Coltene Fill-UpTM) or conventional, layered (BE) (Coltene Brilliant Everglow) composite. Allocation was concealed during cavity preparation. Only the operating dentist knew allocation. The outcome was 24 h post-operative sensitivity.
Results:
41 patients were randomised (20/group). Two patients from FU group were excluded from analysis (factors unrelated to intervention). There was no difference in postoperative sensitivity at 24 h nor any time point. Only participant age and baseline sensitivity scores significantly impacted post-operative sensitivity. One restoration debonded in FU group at 10 days, with no other adverse effects. No difference in time taken to place restorations was seen.
Conclusions:
Within the study's limitations, post-operative sensitivity after class II posterior restorations was no different in bulk-fill restorations compared with conventional, incrementally cured composite.
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Experimental Designs
Crossover Experiments
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs