Evaluating the efficiency of a novel pulpotomy medicament in treating mature permanent teeth with irreversible pulpitis: An in vivo study

This study will be performed to compare and evaluate the clinical and radiographic effectiveness of simvastatin as a pulpotomy medicament in comparison with MTA for managing mature permanent teeth with irreversible pulpitis. Thirty patients with signs and symptoms of irreversible pulpitis will be randomly assigned to two groups: Group I: MTA pulpotomy, Group II: Simvastatin pulpotomy. Informed consent will be obtained from all the patients selected for the study. Pre-operative pain scores will be recorded using a visual analog scale. The entire procedure will be carried out adhering to strict aseptic techniques and under magnification. Local anesthesia will be administered using 2% lignocaine containing 1:80,000 epinephrine. Following rubber dam isolation and cavity disinfection, complete caries excavation and deroofing will be performed. The coronal pulp was amputated to the level of the canal orifice using a large round bur. Following full pulpotomy, hemostasis will be achievedby applying a sterile cotton pellet moistened with 5% NaOCl for up to 10 minutes under light pressure and respective pulpotomy medicament will be placed. In the experimental group, subsequent to the placement of pulpotomy medicament, a layer of MTA will be placed over simvastatin. In both the groups, RMGIC base will be placed and the final restoration will be completed with composite resin. An immediate post-operative radiograph will be taken. Patients will be instructed to record their post-operative pain scores on the provided Visual Analogue Scale, marking the level that best described their pain at 24 hours, 48 hours and 1 week. Patients experiencing pain will be prescribed analgesics. Follow-ups will be scheduled at 6 months and 12 months post-operatively. During these follow-ups, the success of the treatment will be evaluated based on clinical criteria including post-operative pain scores, vitality, presence or absence of swelling, sinus tract formation, tooth mobility and normal functionality of the tooth, along with radiographic criteria such as the presence or absence of periapical pathology, calcification, and resorption. If Simvastatin is proven to be as effective as MTA, it would be beneficial due to its cost-effectiveness.