Impacted mandibular third-molar surgery commonly causes early postoperative pain, swelling, and trismus. This randomized, controlled, three-arm parallel trial evaluated whether intra-alveolar corticosteroid delivery via an absorbable gelatin sponge improves postoperative recovery compared with a saline control. Fifty-five patients were assessed for eligibility; 37 healthy adults (18–35 years) undergoing standardized mandibular third-molar extraction were randomized to dexamethasone 8 mg (Decort®), methylprednisolone 40 mg (Prednol®), or control (saline), all applied intra-alveolarly using a gelatin sponge carrier. Doses were selected using standard systemic glucocorticoid equivalence tables as a pragmatic potency reference, acknowledging unknown intra-alveolar pharmacokinetics/bioavailability. The prespecified primary endpoint (used for sample size planning) was postoperative Day 1 VAS pain; key secondary endpoints were Day 1 analgesic consumption and Day 3 facial swelling. Pain (VAS), analgesic use, trismus, and facial swelling (tragus–pogonion, tragus–labial commissure, and angulus–canthus distances) were assessed on postoperative Days 1, 2, 3, and 7 by a blinded evaluator. Two participants in the methylprednisolone group did not attend postoperative visits. To address potential attrition bias, an Intention-to-Treat (ITT) sensitivity analysis using conservative control-median imputation was performed alongside the available-case analyses. A global False Discovery Rate (FDR) correction was also applied to control for multiplicity. In both analyses, the steroid groups showed lower Day 1 pain scores than the control group. Methylprednisolone was associated with lower Day 3 swelling values than control for the tragus–pogonion and angulus–canthus measurements. These findings should be interpreted as preliminary, given the small sample size, linear swelling measurements, and lack of blinding verification.
Sahebpanah et al. (Tue,) studied this question.