Comparative evaluation of post operative pain associated with Continuous Chelation Irrigating technique using Conventional and Novel Machine-Assisted Irrigating System in symptomatic irreversible pulpitis teeth - A Randomized Clinical Study

1.     In this clinical trial the assessors will be blinded, participants and investigator will be aware of the intervention.

2.     The source of data will be 80 patients, aged between 18 to 80 years, who will be visiting the Department of Conservative Dentistry and Endodontics.

3.     The patient will undergo a clinical examination and radiological diagnosis.

4.     A simple random sampling (www.randomizer.org) will be used to divide study participants into 2 groups.

GROUP 1- Continuous chelation technique with conventional irrigation method for evaluating postoperative pain (n=40) ; sub group for evaluating antimicrobial efficacy of selected participants (n=18)

GROUP 2 – Continuous chelation technique with Continuous auto-irrigation system with warm NaOCl, cold saline and HEBP for evaluating postoperative pain (n=40) ; 

sub group for evaluating antimicrobial efficacy of selected participants (n=18). Here time gap will be maintained while using different irrigants.

All treatment procedures will be carried out by a single operator.

1.     Strict aseptic condition is maintained by using 0.2% chlorhexidine as an oral rinse before isolation of rubber dam, 30% H2O2 and 2.5% NaOCl for 30 s will be used for disinfection of the crowns and surrounding structures. After disinfection protocol, the NaOCl will be inactivated using 5% sodium thiosulfate.

2.     Administration of local anesthesia will be done and tooth of interest will be isolated using rubber dam.

3.     Access opening will be done with sterile Endo access bur under cooling with sterile saline solution, according to conventional endodontic access cavity preparation, while maintaining disinfection protocol.

4.     The contents of the root canal will be debrided by using sterile 15 k file (Mani) with push pull motion

5.      Sterile saline solution will be then incorporated within the canal.

Sample collection: Of 40 participants in each group, 18 of them will be selected randomly by tossing a coin for microbial analysis

·       Sample will be collected from the root canal of single rooted teeth, under aseptic condition as follows

·       Two sterile paper points will be placed in the canal for 60sec and later it will be proceeded to ependroff tubes containing Reduced Transport Fluid (RTF) which serves as a transport media. These samples will be the initial pre-irrigation sample and will be specified as Sample no.1 (S1).

6.     By using electronic apex locater, working length will be determined 1mm short of the apex and will be confirmed with radiograph.

HEBP solution is prepared by dissolving two capsules of HEBP (Twin Kleen) in 10ml of 2.5% NaOCl.

2.     Cleaning and shaping of the canal will be done with appropriate method based on the configuration of the canal.

Group 1 - Final irrigation is done by Continuous chelation technique with

conventional irrigation method

Group 2 - Final irrigation is done by Continuous chelation technique with

continuous auto-irrigation system with warm 2.5% sodium hypochlorite, cold

saline and HEBP.

3.     Post irrigation sample (S2) collection will be done as described earlier from the same randomly selected 36 patients.

4.     After collection of post- irrigation samples, the canals of all the groups will be rinsed with sterile saline.

5.     Calcium hydroxide intracanal dressing will be given and cavit will be placed on the teeth, for a week.

6.     VAS scale chart will be given to every patient to keep track of their intensity of pain at the following intervals- 6 hours, 24 hours, 48 hours, 72 hours, 5th day and 7th day.

Patients will receive a thorough explanation of the VAS before being given instructions on how to mark the horizontal VAS line at various intervals, with the mark representing their intensity of postoperative pain. Patients will be instructed to only take the recommended medicine if they believe the pain is interfering with their daily activities, and to record this in their pain chart. A reminder call will be given to the participants for recording the score by the assessor. The scoring of VAS scale is as follows;

0 – No pain

1-3 – Mild pain

4-6 – Moderate pain

7-10 – Severe pain

The second part is to record the frequency of analgesics used and their effect on pain sensation. Same analgesic will be recommended (Paracetamol - SOS) to all patients. In the second section, the following criteria were used:

Score 0: no pain

Score 1: mild pain that did not require analgesia

Score 2: moderate pain that was controlled with painkillers and did not interfere

with sleep or daily activities

Score 3: unbearable pain that was not controlled by analgesia and interfered with

daily activities

7.     Obturation will be done after 1 week with gutta percha and AH-plus sealer, as per the standard protocol

8.     The final restoration will be done with composite resin as a post endodontic restoration followed by crown placement.

Microbial culturing:

1.     Pre- and post-irrigation samples for microbiological procedures will be collected during the same appointment from both the groups in reduced transport fluid and transferred immediately to the department of microbiology for microbiological analysis, in the college of fisheries, Mangalore

2.      Inoculation of samples will be on 5% Columbia sheep blood agar plates with the help of micropipette. By using a Bunsen burner, the inoculation loop will be heated until it is red hot. Streaking will be done on agar plates after the temperature of loop has cooled to room temperature.

3.     Agar plates will be placed in the incubator at 37oC for 24 hrs

4.     After 24hrs bacteria growth will be counted as Colony forming units (CFUs) by using manual counting method.

af  Thus, post operative pain and antimicrobial efficacy will be evaluated and compared among the group.