A comparative evaluation of the effect of diclofenac sodium with and without per-orally administered methylprednisolone on the sequelae of impacted mandibular third molar removal: A cohort randomized double-blind clinical trial

Abstract

Aim and objectives: This study evaluated the efficacy of oral methylprednisolone and diclofenac sodium on post-operative sequelae after third molar surgery.

Settings and design: A randomized double-blind clinical trial was conducted (with institutional and university approval for dissertation) to evaluate the effect of methylprednisolone with diclofenac sodium (group A) as compared with diclofenac sodium and placebo (group B) on three variables: Pain, swelling and trismus, after third molar surgery.

Materials and methods: Thirty consecutive consenting patients for surgical removal of mandibular impacted third molar were randomly placed into two groups of 15 each (groups A and B). Pain, swelling and trismus were observed by visual analog scale, facial measurements and inter-incisal opening. Scores were recorded after 24 and 72 h and on the seventh post-operative day. Results were subjected to the Chi-square test and independent sample t-test (P = 0.05).

Results: Mean difference in pain experienced between the two groups was statistically significant at 24 h (P = 0.015) and 72 h (P = 0.001) and on the seventh day (P = 0.005). Difference in inter-incisal distance was insignificant (P = 0.239) pre-operatively, but significant after 24 h (P = 0.014) and 72 h (P = 0.001) and on the seventh post-operative day (P = 0.001). Mean difference in swelling was highly significant after 24 h (P = 0.001) and 72 h (P = 0.0001) and on the seventh post-operative day (P = 0.047).

Conclusions: The combination of oral dose of methylprednisolone (a corticosteroid) diclofenac sodium (a non-steroidal anti-inflammatory drug) was found to be more effective than diclofenac sodium alone on the sequelae of surgical removal of impacted mandibular third molar.

Keywords: Glucocorticosteroid; non-steroidal anti-inflammatory drug; pain; swelling; trismus.

Figure 1

Three facial measurements between five reference points: Mandibular angle (G), tragus (T), lateral canthus of the eye (L), outer corner of the mouth (A) and soft tissue pogonion (P) using a measuring tape

Figure 2

Measuring maximal distance between the right maxillary and the mandibular incisor with a vernier caliper

Graph 1

Comparing mean pain experienced on the VAS by patient group A and patients group B

Graph 2

Comparing the mean inter-incisal distance between group A and group B

Graph 3

Comparing the mean facial measurement between group A and group B