1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [naveenprasath.96@gmail.com].
   


6. For how long will this data be available start date provided 25-03-2024 and end date provided 30-05-2025?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

AIM

The aim of this in-vivo study is to compare and evaluate the effect of intracanal cryotreated sodium hypochlorite on post obturation pain in single visit root canal treatment with and without the final rinse with cryotreated normal saline.

MATERIALS AND METHODS

A total of 75 patients with symptomatic irreversible pulpitis with normal periapical tissues / symptomatic apical periodontitis in mandibular premolars which require root canal therapy will be randomly selected. Conventional access cavity will be prepared under local anaesthesia and rubber dam isolation, followed by working length determination and cleaning and shaping will be completed using Hyflex CM rotary files upto 30/0.4 size. Copious irrigation with 5.25% NaOCl and 17 % EDTA will be carried out during the use of each file and the irrigants will be activated using endoactivator. After cleaning and shaping, all samples will be randomly divided into 3 groups as per the final irrigation protocol to be followed.

Group 1: 20 ml of room temperature 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with room temperature normal saline.

Group 2: 20 ml of cryotreated (2-4⁰ C) 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with room temperature normal saline.

Group 3: 20 ml of cryotreated (2-4⁰ C) 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with cryotreated (2-4⁰ C) normal saline.

After the irrigation procedure, all the canals will be dried using paper points and obturated followed by composite restoration of the access cavity. Post operative pain will be assessed by patients at the time intervals of 6 hrs, 12 hrs, 24 hrs, 48 hrs, 4 days and 7 days with the help of 10 cm Heftparker visual analogue scale (VAS). All the patients will be instructed not to take any prophylactic analagesics as, it might affect the outcome of the study and the results will be collected after one week and statistically analysed to carryout inter group comparison.

CLINICAL IMPLICATION :

Post operative pain is very common, affecting almost 60% of the subjects who have undergone endodontic treatment. Given that post-operative endodontic pain has a multi-factorial etiology, and being influenced by a variety of factors related to the subject and the tooth being treated, several strategies have been proposed to control post-operative endodontic pain. One such method is intracanal cryotherapy, in which the cryotreated irrigant solution is used to irrigate the prepared root canals to reduce the temperature of surrounding tissues. Most of the studies have shown that, reducing the root surface temperature will decrease the inflammation in periapical area leading to reduction of post operative pain. Since it is a simple and technique insensitive procedure, it can be used in routine clinical practice effectively to control the occurrence of post operative pain.