Assessment of Post operative pain after the use of a calcium silicate based sealer. A randomized controlled clinical trial.

The bioceramic materials have been shown to be less cytotoxic compared with resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro. The new bioceramic sealer, Bioroot RCS (Septodont) is a water soluble sealer composed of tricalcium silicate, zirconium oxide, and calcium chloride. When in contact with physiologic solutions, these sealers release calcium ions, thereby forming an interfacial calcium phosphate (apatite) layer. This helps in developing a favorable chemical bond with the dentinal walls. Many studies have reported that BioRoot RCS has excellent flow, radiopacity and biocompatibility.However, AH exhibited stronger bonding capacity and higher radiopacity  compared with bioceramic sealers. The clinical significance of these characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are scarce and of great interest. The null hypothesis states that there will be no difference in post operative pain of BioRoot RCS sealer when compared with AH Plus.

Objectives-

1.     Evaluate the post- instrumentation pain caused by Bio Root RCS compared to AH Plus as a sealer for obturation after cleaning & shaping .

2.     Sub group analysis for gender, pulp vitality status and periapical status will be performed.

Root canal procedure:

·   Diagnosis will be confirmed based on the clinical examination and periapical x-rays. Only teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al  will be included. Cases with a widened periapical periodontal space and inadequate root canal filling corresponded to a score of 2 will be included. Teeth with large periapical lesions (score 5) will be excluded to minimize the chances of exacerbation of the local inflammatory process. Before initiating the treatment base line parameters such as age, gender, pulp status, number of cavity wall defects, diagnosis, periapical lesion are recorded.

·  During the first appointment, an access cavity will be prepared using 014 round carbide and Endo Z burs (Dentsply International, York, PA, USA) under local anaesthesia (lidocaine hydrochloride and epinephrine 1:80,000; Xilonibsa, Inibsa, Spain) and rubber dam isolation following which the root canals will be located.

·   Working length will be established 0.5mm short of the minor foramen, using a propex pixi apex locator (dentsply mallifer), which will be confirmed radiographically.  Cleaning and shaping will be done using Mtwo files. Master apical file preparation between # 25 to #40 according to initial apical file. 17% EDTA gel will be used as the lubricant with the Mtwo file system.

IRRIGATION PROTOCOL:

·      Irrigation with 3 mL of 3% NaOCl (Parcan; Septodont, Delhi, India) will be  performed between each file. After instrumentation of the root canal, 5 mL of 17% Ethylenediamine tetraacetic acid (17% EDTA) solution (Dent Wash; Prime Dental Products Pvt. Ltd., Thane, India) will be used for smear layer clearance. Following this, irrigation with 5 mL of 0.9% physiological saline solution will be done. All the above will be done using a 30-gauge side vented needle (Maxi-I-probe; Dentsply, Tulsa Dental, York, PA, USA), 1 mm short of working length.  In both the groups, passive ultrasonic irrigation will be performed by ultrasonically passively activating 1 ml of 3% sodium hypochlorite (NaOCl) in the root canal using a stainless-steel #15 K-type file mounted in a piezoelectric ultrasonic device (Enac-Osada, Tokyo, Japan) at a power setting of 3 for 20 seconds followed by 0.5 mL 3% NaOCl for 10 seconds to the working length (WL). This 30-second cycle will be repeated 3 times. The ultrasonic instrument will be used at 1 mm short of the WL. Smear layer will then be removed using 2 mL of 17% Ethylenediaminetetraacetic acid (EDTA) activated for 60 seconds with a total contact time of 2 mins with the canal walls and activated in the same manner, followed by a final rinse with 2 mL of distilled water activated for 1 min.

Patients will be randomised to the following groups:

1.     Group 1: Calcium silicate  based sealer (BioRoot RCS)

2.     Group 2: Resin Based sealer (AH plus).

OBTURATION :

·      The root canal sealer will be prepared according to the manufacturer’s instructions. After drying with paper points, a small amount of the sealer was introduced into the canal with a smaller gutta percha point. A master gutta-percha point will be adapted, and the canal was obturated by lateral condensation using lateral gutta percha points. Post-instrumentation pain data will be recorded in VAS scale at 2,4,6,8,24,48 hours through phone call to the patient.

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