Discussion
Tissue damage, postoperative pain, swelling, Pain, lower pain, edema, inflammation, inflammation sequelae, pain, abscess, Erdil, necrosis, postoperative sequelae, trismus, MP, trauma
ADVERSE EVENTS, EDEMA, INFLAMMATION, DRUG EFFECT, ABSCESS, SECONDARY, SEQUELAE, FACIAL EDEMA, NECROSIS, TRISMUS, COMPLICATIONS
Tissue damage arising from surgical trauma in M3M removal often results in common postoperative inflammatory sequelae, such as swelling, trismus, and pain, which negatively affect the patient's quality of life, especially immediately after surgery [In this split-mouth randomized clinical trial, we analyzed the effects of the pre-operative use of prednisone (25 mg/os) on inflammation sequelae caused by M3M surgical removal in a cohort of 32 patients. Data were collected at two different time points, specifically at 2 and 7 days, after surgery. This study's primary outcome was to compare the efficacy of prednisone/os vs placebo in reducing facial swelling using three-dimensional qualitative and quantitative analysis. The secondary outcome was to assess the effects of prednisone/os administration on trismus and pain.Although both groups experienced facial swelling after the removal of M3M, patients treated with prednisone (PG) showed significantly less facial swelling and pain at both T1 and T2 compared to the placebo sample (CG). However, the T1-T2 evaluation showed a greater reduction in facial swelling compared to the control group. No significant associations with trismus were observed. It is important to note that these results were unbiased both for the invasiveness and the length of the surgical procedure, as no differences between the two study groups existed in terms of surgical risk stratification (Daugela et al.) and surgical time of M3M removal. In line with our data, Tiigimae-Saar et al. conducted a prospective study showing that the administration of prednisolone can be effective in reducing edema, especially in the first four days following M3M removal surgery [In our study, we selected prednisone for the pre-surgical therapeutic approach. Prednisolone and prednisone belong to glucocorticoids and share the same mechanism of action [In line with preliminary studies by Kim and Yuasa, our correlations between surgery duration and facial swelling showed that a longer surgical time was significantly associated with larger edema both at T1 and T2 in the groups, with no difference between PG and CG [Pain assessment showed an increase in symptoms at T1, followed by a subsequent decrease at T2 for both PG and CG. Comparing the two patient groups, PG reported less pain than CG at both time points. According to our results, oral prednisone administration one hour before surgery was correlated with lower pain compared to placebo, especially seven days after surgery, thus improving the patient's quality of life. As shown by Acham et al., a single oral administration of methylprednisone 1 h before surgery is significantly effective in monitoring postoperative pain during the first week of follow-up [Evaluation of maximum mouth opening revealed a significant decrease at T1, regardless of patient groups. Despite symptom improvement for PG and CG, postoperative inflammation continued to have a negative effect on mouth opening at follow-up T2 with no significant differences between the two groups. These findings are in agreement with Buyukkurt et al., who previously reported that although prednisolone administration results in a clear improvement in pain, it is not associated with better effects on post-surgical trismus than placebo [This evidence is reported by several authors who point out an improvement in postoperative sequelae by taking corticosteroids with incomplete disappearance of symptoms such as pain and trismus beyond one week of follow-up [The efficacy of corticosteroid-based therapy in reducing post-surgical discomfort in oral surgery has been widely investigated in the literature [A literature review on M3M surgery from 2000 to 2020 clearly highlighted a high interest in the scientific research around the administration of corticosteroids and around i) the most appropriate type of drug, ii) the best administration route, and iii) the most effective dosage for the management of post-surgical inflammatory symptoms and for the patient's quality of life improvement [As reported in several studies, the short duration of action and moderate dosage of MP are sufficient to manage inflammatory symptoms while avoiding possible systemic complications. However, many authors prefer the use of DM due to its greater anti-inflammatory potency, its prolonged drug effect (> 36 h), or the repeated administration of steroids in the following days [So far, several administration routes for corticosteroids have been proposed, including intravenous, intramuscular, submucosal, and oral. The intravenous route of administration shows the advantage of leading to a rapid increase of drug concentration within plasma; intramuscular and submucosal administration provide encouraging data on the treatment efficacy. However, the former is characterized by slow onset and increased risk of HPA axis disruption, while the latter may cause local adverse events such as tissue necrosis or abscess at the injection site [As previously reported, the best dosage depends on the type of corticosteroid used. Despite this general concept, most of the available studies showed that a high dosage effectively manages inflammatory sequelae due to oral surgery procedures.While Mojsa et al. showed that the submucosal administration of 4 mg Dexamethasone is necessary to manage the M3M comorbidities, Erdil et al. suggested a double dosage equal to 8 mg [Moreover, in a review by Ngeow WC et al., it is reported that to achieve the same effects of 10 mg prednisolone, it is necessary to prescribe 8 mg methylprednisolone or 50 mg cortisone, or 40 mg hydrocortisone (cortisol), or 1.5 mg betamethasone or dexamethasone [The results of our study suggest that pre-emptive short-term therapy of low doses (25 mg/os) of prednisone is effective compared to placebo in the management of postoperative symptoms caused by M3M removal. This concept is in accordance with a recent systematic review suggesting that pre-operative administration of corticosteroids is clinically preferable, but without identifying the optimal dosage and route of administration [Overall, our study shows strengths but, at the same time, weaknesses that need to be kept in mind in order to analyze the results correctly. Starting with the strengths, to our knowledge, this is the first study evaluating the efficacy of prednisone administration prior to M3M removal through the correlation of surgical difficulty assessed by CT scan-based grading and through the analysis of outcomes with 3D facial imaging technology.Moreover, the use of very strict inclusion criteria for the enrollment of patients, as well as the triple-blind clinical study design, are certainly other major strengths of our study.The splith-mouth design used in our study (i.e. bilateral removal of M3M with similar position and degree of surgical risk in the same patient) is quite similar to other splith-mouth randomized clinical trials [Furthermore, the assessment of facial edema using 3D scans is more predictable and accurate than other empirical procedures [In particular, as highlighted by Dzelzkaleja et al., who analyzed the performance of several apps, Bellus3D FaceApp is effective in keeping face scans compliant, with simple and fast image acquisition, avoiding the deformation of the scanned model [On the other hand, our study has some limitations, mainly represented by the small sample examined, including only M3Ms with simple or moderate surgical risk. A further limitation might be the lack of an objective method of pain assessment.