| 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
|
|
|
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
|
|
|
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.
|