| 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
|
|
|
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). |