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CTRI Number  CTRI/2024/04/065759 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of post treatment pain using two different Irrigating techniques in symptomatic irreversible pulpitis teeth 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anivarth A Rao 
Designation  Post Graduate student (MDS - Conservative Dentistry and Endodontics)) 
Affiliation  Srinivas Institute of Dental Sciences, Mangalore 
Address  Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore

Dakshina Kannada
KARNATAKA
574146
India 
Phone  9632216200  
Fax    
Email  ranivarth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kishan KV 
Designation  Professor and Head of the Department , Conservative Dentistry and Endodontics 
Affiliation  Srinivas Institute of Dental Sciences, Mangalore 
Address  Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore

Dakshina Kannada
KARNATAKA
574146
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Kishan KV 
Designation  Professor and Head of the Department , Conservative Dentistry and Endodontics 
Affiliation  Srinivas Institute of Dental Sciences, Mangalore 
Address  Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore

Dakshina Kannada
KARNATAKA
574146
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Source of Monetary or Material Support  
Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Dakshina Kannada, Karnataka, India - 574146 
 
Primary Sponsor  
Name  Dr Anivarth A Rao 
Address  Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Dakshina Kannada, Karnataka, India - 574146  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anivarth A Rao  Srinivas Institute of Dental Sciences  Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore- 574146
Dakshina Kannada
KARNATAKA 
9632216200

ranivarth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas Institute of Dental Sciences Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Irrigating System (Conventional Syringe)  Continuous Chelation Irrigating Technique performed as a final irrigation protocol for five minutes using Conventional Irrigating System 
Intervention  Novel Machine-Assisted Irrigating System (A-CIS IRRIGATOR)  Continuous Chelation Irrigating Technique performed as a final irrigation protocol for five minutes using Novel Machine-Assisted Irrigating System  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Permanent single rooted tooth
2.Patient with symptomatic irreversible pulpitis OR symptomatic apical periodontitis as confirmed using radiographs and pulp vitality test.
3.Patient with mild to moderate preoperative pain with VAS score of ≤ 6
4.Non-contributory medical history

 
 
ExclusionCriteria 
Details  1.Internal and external resorption
2.Calcified canals
3.Root Perforation
4.Extensive destruction of crown
5.Periapical lesion of ≥ 2 mm
6.Root fracture
7.Periodontically compromised tooth.
8.Antibiotics taken in past 3 months.
9.History of previous endodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the post operative pain after using Conventional Irrigating system and Novel Machine-Assisted Irrigating System (A-CIS IRRIGATOR) in symptomatic irreversible pulpitis teeth using Visual Analogue Scale.   6 hours, 24 hours, 48 hours, 72 hours, 5th day and 7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare Antimicrobial efficacy of pre & post irrigation samples between Conventional Irrigating system & Novel Machine-Assisted Irrigating System (A-CIS IRRIGATOR) using colony forming unit count  1 day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/05/2024 
Date of Study Completion (India) 25/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/02/2026 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.  

Results: A-CIS Irrigator showed significantly lower VAS from 6h to day 5, pain-free by 72h. Conventional syringe irrigation with HEBP achieved pain-free status by day 7. No analgesics needed in the A-CIS group. Microbial Outcomes showed that A-CIS group showed superior in reduction of aerobic bacteria 

 Conclusion: The novel automatic irrigation system outperformed conventional syringe irrigation (with HEBP) in symptomatic irreversible pulpitis cases. It achieved lower VAS pain, faster pain-free status, and fewer analgesics required. Aerobic bacterial reduction was superior despite a higher baseline; anaerobe count showed equivalent results with conventional irrigation with HEBP.







 
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