FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091392 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Occurrence of Pain Post-Root Canal Therapy Using Different Root Canal Instruments 
Scientific Title of Study   Comparison of Post-Operative Pain in Endodontically Treated Teeth with Asymptomatic Irreversible Pulpitis with Two Rotary File Systems and Two Endodontic Motors: A Randomized 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  Dr R Anitha Kumari 
Designation  Professor & Head of Department 
Affiliation  Vokkaligara Sangha Dental College & Hospital 
Address  Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004

Bangalore
KARNATAKA
560004
India 
Phone  9845919324  
Fax    
Email  anithamanasi18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Simran Baliga 
Designation  Postgraduate Student 
Affiliation  Vokkaligara Sangha Dental College & Hospital 
Address  Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004

Bangalore
KARNATAKA
560004
India 
Phone  9535491935  
Fax    
Email  simran.baliga@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Simran Baliga 
Designation  Postgraduate Student 
Affiliation  Vokkaligara Sangha Dental College & Hospital 
Address  Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004

Bangalore
KARNATAKA
560004
India 
Phone  9535491935  
Fax    
Email  simran.baliga@hotmail.com  
 
Source of Monetary or Material Support  
Self Funded; Site of Study: Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka 560004 
 
Primary Sponsor  
Name  Dr Simran Baliga 
Address  Postgraduate Student Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Simran Baliga  Postgraduate Student Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Anitha Kumari  Vokkaligara Sangha Dental College & Hospital  Room No: 6, Department of Conservative Dentistry & Endodontics Vokkaligara Sangha Dental College & Hospital, K.R. Road, V.V. Puram, Bengaluru, Karnataka-560004
Bangalore
KARNATAKA 
9845919324

anithamanasi18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kempegowda Institute of Medical Sciences Institutional Ethics 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  2 Rotary File Systems   2 Rotary File Systems i.e., Epident V+ Gold File System and ProTaper Gold File System 
Intervention  Root Canal Preparation with 2 Different Rotary File Systems and Endomotors   Root Canal Preparation with 2 Different Rotary File Systems and Endomotors Estimated Total Duration of Study: 6 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Maxillary premolars of patients aged 20 to 50 years
2) Mature apices
3) Asymptomatic
4) Diagnosis of irreversible pulpitis with or without apical periodontitis (determined using cold and electric pulp test)
5) Written informed consent prior to study procedure
 
 
ExclusionCriteria 
Details  1) Analgesic consumption within 24 hours
2) Greater than 25° root canal curvature
3) Complex root canal morphology
4) Re-treatment / Re-root canal treatment
5) Allergic reactions
6) Presence of evidence of any other periapical pathologies
7) Any systemic disease
8) Pregnancy or breastfeeding
9) Inability to understand or provide consent for procedure
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain recorded using the Visual Analogue Scale with scores ranging from 0-10  Baseline i.e., pre-treatment pain 
 
Secondary Outcome  
Outcome  TimePoints 
- To check if integrated apex locator is more efficient than conventional endomotors
- To check if 2 different file systems are similar or different in shaping efficiency
 
- Pre- and Post- treatment pain
- Post- Treatment pain at 0 hrs, 24 hrs, 48 hrs, 72 hrs and 7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   20/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Root canal treatment is a commonly performed dental procedure which is performed when the pulp of the tooth is irreversibly damaged. Devices like the apex locator and endomotor are used as part of the procedure along with other instruments. The apex locator allows the dentist to locate the apex of the tooth and the endomotor allows the operator to clean and shape the root canal of the tooth. 

Although these devices are available separately, recently there have been new ’integrated’ endomotors introduced which combine these devices into a single device i.e., an endomotor with an in-built apex locator. Along with these devices, rotary files are used to clean and shape the root canal of the tooth. These files may be of many sizes, cross-sectional shapes and configurations, made of different materials with other differences. The literature comparing different commercially available file systems is vast, however the literature comparing a new file system along with the use of the integrated endomotor is scarce as compared to more commonly used file systems. Pain post root canal treatment is frequently reported and may be due to several factors like extrusion of debris or irrigation solutions beyond the apex of the tooth. This study aims to compare two file systems with an endomotor and integrated endomotor on the incidence of post-operative pain.

RESEARCH QUESTION:

Is there a difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors?

RESEARCH HYPOTHESIS (H1):

There is a difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors

NULL HYPOTHESIS (H0):

There is no difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors


Pre-operative pain will be recorded as the baseline.

Post-operative pain in all participants will be recorded using the Visual Analogue Scale (VAS) with scores ranging from 0 to 10. 


The intensity of pain perceived by the participant will be assessed at the time intervals of 24 hours, 48 hours, 72 hours, and 7 days using the Visual Analogue Scale (VAS).

The pain intensity according to the Visual Analogue Scale (VAS) will be categorized as a score of 0 indicative of no pain or score of 7-10 indicative of severe pain


Pain scores will be subjected to statistical analysis.

The follow-up of the perceived pain will be performed over the telephone by the outcome assessor not part of the study at time intervals of 24 hours, 48 hours, 72 hours, and 7 days using the Visual Analogue Scale (VAS).


 
Close