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CTRI Number  CTRI/2025/09/095172 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate reduction in post operative pain after single visit root canal treatment in non vital teeth after using Er:YaG laser therapy 
Scientific Title of Study   Randomised control study to evaluate incidence of post operative pain following single visit endodontics in non vital teeth using Er:YaG laser 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NEHA PRASHAR 
Designation  DENTAL OFFICER 
Affiliation  MINISTRY OF DEFENCE 
Address  SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS ) MILITARY DENTAL CENTRE (GL) GOUGH LINES SECUNDERABAD

Hyderabad
TELANGANA
500015
India 
Phone  9765271410  
Fax    
Email  drdentistneha@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr NEHA PRASHAR 
Designation  DENTAL OFFICER  
Affiliation  MINISTRY OF DEFENCE 
Address  SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS ) MILITARY DENTAL CENTRE (GL) GOUGH LINES SECUNDERABAD

Hyderabad
TELANGANA
500015
India 
Phone  9765271410  
Fax    
Email  drdentistneha@outlook.com  
 
Details of Contact Person
Public Query
 
Name  Dr NEHA PRASHAR 
Designation  DENTAL OFFICER 
Affiliation  MINISTRY OF DEFENCE  
Address  SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS ) MILITARY DENTAL CENTRE (GL) GOUGH LINES SECUNDERABAD

Hyderabad
TELANGANA
500015
India 
Phone  9765271410  
Fax    
Email  drdentistneha@outlook.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Ministry of Defence OO DGDS 
Address  Military Dental Centre (GL) Gough Lines, Secunderabad , Telangana, India Pin 500015  
Type of Sponsor  Government funding agency 
 
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 Neha Prashar  Military Dental Centre (GL) Secunderabad  Surgery No 4 ( Conservative Dentistry & Endodontics) Military dental Centre (GL) Gough Lines , Secunderabad Pin -500015
Hyderabad
TELANGANA 
9765271410

drdentistneha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army College of Dental Sciences Institiutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional syringe Irrigation   Use of conventional syringe irrigation or manual irrigation with saline /sodium hypochlorite solution to flush debris and disrupt microbial biofilm in root canals . 
Intervention  Er:YaG laser activated irrigation  Use of Er:YaG laser to disrupt microbial biofilm & canal disinfection through acoustic streaming & cavitation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Multirooted tooth with a diagnosis of pulp necrosis, showing apical periodontitis (1mm-2mm) as confirmed by radiovisiography
2.No spontaneous pain
3.No contributory medical history
 
 
ExclusionCriteria 
Details  - Medically compromised patient
-Teeth with pus discharge
-Anatomic variations
-Patients not on analgesics or sedative medication prior to
root canal therapy
-Teeth without sinus tract
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Er: YaG is an effective method for disinfection to provide painless single sitting RC in a non vital multirooted tooth .  The patient will be evaluated at 12 hrs, 48 hrs and 72 hrs post treatment for pain assessment using VAS  
 
Secondary Outcome  
Outcome  TimePoints 
nil   nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   30/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Historically, Rootcanal treatment reminds of painful  long multiple sitting. With advances in  research and technology single visit endodontics has gained acceptance. Success of root canal treatment depends on proper cleaning , shaping & disinfecting the canals& hermetically sealing the canals. Very few studies have been carried out to compare the effectiveness of Er:YaG laser in  single sitting endodontic treatment for non-vital tooth. In our fast pacing & committed life, Successful Single visit endodontics  is the  treatment of choice. However , painless procedure followed by predictable  treatment outcome is still a challenge.

Aim of the study is to find  the Incidence of post-operative pain following single visit endodontics in  non-vital teeth , using Er:YAG laser

i) To compare treatment outcome of single visit endodontics in non vital teeth against the conventional treatment and study pattern of pain post operative  after 1st day ,3rd day & 5th  day using Visual analogue scale .

In this prospective clinical study, 60 multirooted teeth indicated for endodontic treatment were treated by a single endodontist according to a preestablished protocol. The teeth were randomly divided into four groups (n = 30).

Group 1 – Single sitting endodontics with use of Er: YAG laser & Sodium hypochlorite as last irrigant .

Group 2 – Single sitting endodontics with use of conventional syringe for irrigation with sodium hypochlorite as last irrigant .

The patients will be allotted in all work groups using block randomization. All the cases will be studied for pattern of pain after 12, 48 and 72 hrs of endodontic treatment, patients’ pain post operatively will be evaluated telephonically through a Visual Analog Scale (VAS) ranging from 0 to 10. Scale 0-6 will be evaluated as mild to moderate pain manageable with & without analgesics. Scale 0-7 will be evaluated as severe pain not manageable by medication, requiring clinical re-evaluation. In all workgroups, similar protocols were used for instrumentation with the Protaper files & strictly adhering to the working length , irrigation with 2.5% sodium hypochlorite, and 6% Gutta Percha for obturation will be used . All treated tooth will be de-occluded post obturation. Informed consent of the patient will be taken prior to the treatment.

The data obtained will be analysed statistically for any significant post operative pain in single sitting endodontic treatment in  non vital tooth after 12, 48, 72 hrs evaluation and between the group.


 
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