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CTRI Number  CTRI/2026/02/104988 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   ANTIMICROBIAL EFFICACY AND POST OPERATIVE PAIN FOLLOWED BY LASER ACTIVATED IRRIGATION AFTER A SINGLE VISIT ROOT CANAL THERAPY IN TEETH WITH PULPAL NECROSIS- A RANDOMISED CONTROLLED TRIAL  
Scientific Title of Study   Antimicrobial efficacy and post operative pain following laser activated irrigation after a single visit root canal therapy in teeth with pulpal necrosis- A randomised controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kushali 
Designation  Student 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India 
Phone  8300528965  
Fax    
Email  kushaliraj2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sathish Sundar 
Designation  Associate Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India 
Phone  9884511763  
Fax    
Email  sathsundar87@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sathish Sundar 
Designation  Associate Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India 
Phone  9884511763  
Fax    
Email  sathsundar87@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai 
 
Primary Sponsor  
Name  Kushali R 
Address  Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai 
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 
Kushali R  Meenakshi Ammal Dental College and Hospital  Department of Conservative Dentistry and Endodontics Meenakshi Ammal Dental College and Hospital , Alapakkam Main Rd, Maduravoyal, Chennai
Chennai
TAMIL NADU 
08300528965

kushaliraj2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Meenakshi Ammal Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pulpalnecrosis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of bacterial load reduction and post operative pain  Reduction in bacterial load and VAS score before and after treatment 
Intervention  Laser and passive ultrasonic irrigation   EVALUATION OF ANTIMICROBIAL EFFICACY AND POST OPERATIVE PAIN FOLLOWING LASER ACTIVATED IRRIGATION AFTER A SINGLE VISIT ROOT CANAL THERAPY IN TEETH WITH PULPAL NECROSIS  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Systemically healthy patients (ASA–1) under the age group of 18- 65 years with a preoperative pain score ranging more than 5 cm on the VAS scale eliciting pain requiring primary root canal treatment in pulpal necrosis in mandibular molars are only considered 
 
ExclusionCriteria 
Details  Teeth with crown or root fracture, periapical cyst, resorption defects, calcifications, aberrant anatomy, sinus opening, sealer extrusion and previous evidence of endodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in bacterial load
2. VAS score  
6hrs, 8hrs, 12hrs, 24hrs, 48hrs and 72hrs 
 
Secondary Outcome  
Outcome  TimePoints 
post operative pain score  At 6, 8, 12, 24, 48 and 72 hours after obturation  
Post operative pain assessment   At 6, 8, 12, 24, 48, 72 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

INTRODUCTION-

The goal of endodontic treatment is to create a sterile, bacteria-free environment inside the tooth as well as the periapical tissue to prevent or treat chronic periapical lesions. Post-operative pain is a common occurrence after endodontic therapy and irrigation plays an important role in disinfecting the root canal and removing bacteria in complex root canal systems. Optimal  endodontic access cavities have demonstrated better outcomes in terms of maintaining tooth integrity while still allowing sufficient access for cleaning and shaping the root canal system. 

Conventional needle irrigation is shown to be the most commonly employed irrigation with sodium hypochlorite but it fails to deliver intricate parts such as fins and ramifications of the root canal system. Irrigation activation modality which has gained recent trend is laser- activated irrigation where Er: YAG, Er, Cr: YSGG, Nd: YAG lasers have been studied extensively as irrigant modality for intracanal bacterial reduction. Diode Laser has been highly acceptable because of its high antibacterial effect and can aid in better irrigation in root canal treatment where conservation access has been performed. A combination of smear layer removal, bacterial reduction, reduced apical leakage are advantages of the laser and make it viable for endodontic treatment.

Sample Size Determination

The sample size to be  determined based on pilot study results using G*Power version 3.1 for Windows. 

Eligibility Criteria 

a. Inclusion Criteria

Systemically healthy patients (ASA–1) under the age group of 18- 65 years with a preoperative pain score ranging more than 5 cm on the VAS scale eliciting pain requiring primary root canal treatment in pulpal necrosis in mandibular molars are only considered.

b.Exclusion Criteria

Teeth with crown or root fracture, periapical cyst, resorption defects, calcifications, aberrant anatomy, sinus opening, sealer extrusion and previous evidence of endodontic treatment

 Setting and Location

The study participants will be recruited from the pool of patients who reported for treatment in the postgraduate section of the endodontics department of the college.

-Randomization

The randomization process to be carried out by a third person who will have  no participation in conducting the study. 

Treatment Procedure

Optimised  preparation of the access cavity to be made with the help of an Endo access bur 1. The canals will be initially scouted using ISO No.8 stainless steel K- file. Working length determination is done using an apex locator using an ISO No.10 stainless steel K-file.

Microbial analysis

Sample (S1) is to be collected after patency with a paper point placed in the canals for 60secs and sample (S2) is to be collected after disinfection protocol is followed using laser and PUI using paper points for 60secs. The samples will be placed in transport medium for further microbiological analysis using PCR. 

The bacterial species to be identified in PCR are 1. Prevotella intermedia ( B. P. F. A. Gomes et al) 2. Enterococcus faecalis(R Gnana Seelan et al) 3. Treponema denticola (J. F. Siqueira Jr et al) 


Irrigation Protocols

As mentioned above on page irrigation protocol will be Followed by the activation of irrigants,  canals obturation with 6% gutta- percha  using AH Plus / bioceramic sealer. The time of completion of the procedure and the postoperative pain scores of 4,  6, 12, 24, 48 & 72 h will be noted. 

Outcome measures

The primary outcome is the reduction of bacterial load will be assessed by the PCR and by level of postoperative pain at 4,  6, 12, 24, 48 & 72 h using the 10 cm VAS scale which will be recorded on a pain diary consisting of the hour and time of assessment.


 
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