Evaluation of Preoperative Intramasseteric Methylprednisolone Hemisuccinate Injection on Postoperative Sequelae in Lower Third Molar Surgery: A Randomized, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate the effect of a preoperative **intramuscular corticosteroid** injection, specifically methylprednisolone hemisuccinate, on the post-operative outcomes of swelling, trismus, and pain following lower third molar surgery. This investigation is clinically relevant as it aims to determine the efficacy of corticosteroid administration in reducing common postoperative sequelae, potentially improving patient recovery and comfort after dental surgery.

The clinical trial focuses on individuals experiencing **postoperative sequelae** following lower third molar surgery. The study population includes both male and female participants, aged between 18 and 50 years, who are in good general health and maintain good oral hygiene. Participants are required to have lower wisdom teeth on both sides, in deeper impaction and similar positions. The trial does not involve a vulnerable population, and participants must not be receiving any medication that could affect the treatment. The sponsor has not provided information regarding the total number of participants in the study.

The clinical trial is designed to evaluate the effect of **methylprednisolone hemisuccinate** on postoperative sequelae following lower third molar surgery. This study is a **randomized, double-blind, placebo-controlled** trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thus minimizing bias. The trial is expected to commence recruitment on January 9, 2025, and conclude by December 31, 2026. The primary objective is to assess the impact of intramuscular corticosteroid injection on postoperative swelling, trismus, and pain.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on criteria such as age (18-50 years), health status, and oral hygiene. Eligible participants must have lower wisdom teeth in similar positions and deeper impaction on both sides. The study excludes individuals on medications that could affect treatment outcomes. Following the screening, participants will be randomly assigned to receive either the active treatment or a placebo.

Throughout the trial, participants will attend follow-up visits to monitor their response to the treatment and any adverse effects. These visits are crucial for collecting data on the primary endpoints, which include postoperative swelling, trismus, and pain. The end-of-study visit will mark the completion of the trial for each participant, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected length of participant involvement is approximately one day, as the maximum treatment period is limited to a single administration of the investigational product. Conditions that may lead to early termination from the study include the occurrence of significant adverse events or withdrawal of consent by the participant. The trial is conducted under the authorization of relevant regulatory bodies, ensuring compliance with ethical standards and scientific rigor.

The clinical trial involves the administration of **SOLU-MEDROL 40 mg/1 mL**, a pharmaceutical formulation consisting of a **poudre et solvant pour solution injectable**. The active substance in this formulation is **methylprednisolone hemisuccinate**, a chemical compound classified under the ATC code **H02AB04**. The medication is provided as a solution for injection and is manufactured by Pfizer Holding France. The maximum daily and total dose of SOLU-MEDROL is 1000 mg, with a treatment period limited to one day. The route of administration is intramuscular injection, specifically targeting the masseter muscle, to evaluate its effects on post-operative sequelae following lower third molar surgery.

In this randomized, double-blinded study, a placebo-controlled design is employed to assess the efficacy of the experimental treatment. The placebo used in the trial is a non-active substance, administered in the same manner as the experimental drug, to ensure blinding and maintain the integrity of the study results. The placebo is designed to mimic the appearance and administration route of SOLU-MEDROL, ensuring that neither the participants nor the investigators are aware of the treatment allocation.

Participant compliance with the dosing schedule is monitored through direct observation and documentation of each injection. The study protocol includes measures to ensure accurate administration and adherence to the prescribed dosing regimen. The trial aims to investigate the impact of the corticosteroid injection on post-operative swelling, trismus, and pain, providing valuable insights into its potential benefits in surgical recovery.

The clinical trial aims to assess the efficacy of **methylprednisolone hemisuccinate** in reducing post-operative sequelae such as swelling, trismus, and pain following lower third molar surgery. The study is designed as a placebo-controlled, randomized, double-blinded trial. Efficacy will be evaluated by measuring the reduction in post-operative symptoms, although specific primary and secondary endpoints are not detailed in the provided data. The trial will involve the administration of the drug via intramuscular injection, with the maximum treatment period being one day. The trial is scheduled to start recruitment on January 9, 2025, and is expected to conclude by December 31, 2026. The study will include participants aged 18 to 50 with specific dental conditions, ensuring they are healthy and not on medications that could affect the treatment outcomes. The trial is categorized as a phase 6 study, focusing on an already licensed product.