| CTRI Number |
CTRI/2025/09/094331 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tooth Pain after Root Canal in Diabetic Patients: Study of Two Treatment Methods |
|
Scientific Title of Study
|
Evaluation Of Postoperative Pain Following Single - Visit Root Canal Treatment With Protaper Gold and Wave One Gold File System In Controlled Diabetic Patients With Irreversible Pulpitis: An In-Vivo Study |
| Trial Acronym |
CANAL-DIAB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubha V Samorekar |
| Designation |
Post Graduate Student |
| Affiliation |
Surendera dental college and research institute |
| Address |
Surendera PG Girls Hostel, Surendera Dental College and Research Institute, HH Gardens, Power House Road, Sri Ganganagar, Rajasthan, India 335001
Room 5, A Block, Department of Conservative Dentistry and Endodontics, Surendera Dental College and Research Institute, HH Gardens, Power House Road, Sri Ganganagar, Rajasthan, India 335001
Ganganagar
RAJASTHAN
335001
India |
| Phone |
8951258183 |
| Fax |
|
| Email |
shubhasamorekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetu Jindal |
| Designation |
Head of the Department |
| Affiliation |
Surendera dental college and research institute, Rajasthan University Of Health and Sciences |
| Address |
Jindal Eye and Dental care, Vriddashram Road, Model Town, Sri Ganganager-335001
Room 5, Department of Conservative Dentistry and Endodontics, A Block, Surendera Dental College and Research Institute, HH Gardens, Power House Garden, Sri Ganganagar, Rajasthan, India 335001
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9929854146 |
| Fax |
|
| Email |
drneetujindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubha V Samorekar |
| Designation |
Post Graduate Student |
| Affiliation |
Surendera dental college and research institute |
| Address |
Surendera PG Girls Hostel, Surendera Dental College and Research Institute, HH Gardens, Power House Garden, Sri Ganganagar, Rajasthan, India 335001
Room 5, Department of Conservative Dentistry and Endodontics, Surendera Dental College and Research Institute, HH Gardens, Power House Garden, Sri Ganganagar, Rajasthan, India 335001
Ganganagar
RAJASTHAN
335001
India |
| Phone |
8951258183 |
| Fax |
|
| Email |
shubhasamorekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Surendera Dental College and Research Institute, HH Gardens, Power House Garden, Sri Ganganagar, Rajasthan, India 335001 |
|
|
Primary Sponsor
|
| Name |
Dr Shubha V Samorekar |
| Address |
Room 5, Department of Conservative Dentistry and Endodontics, Surendera Dental College and Research Institute, HH Gardens, Power House Garden, Sri Ganganagar, Rajasthan, India 335001 |
| 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 |
| Dr Shubha V Samorekar |
Surendera Dental College and Research Institute |
Room No. 5 Department of Conservative Dentistry And Endodontics,A Block, HH Gardens, Power House, Sri Ganganagar - 335001
Ganganagar
RAJASTHAN |
08951258183
shubhasamorekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Root canal treatment using ProTaper Gold File Sytem |
Root canal cleaning and shaping performed using ProTaper Gold rotary system as per manufacture’s guidelines. This involves a rotary technique for bio mechanical preparation of the root canal. |
| Comparator Agent |
Root Canal treatment using WaveOne Gold reciprocating file system |
Root canal cleaning and shaping performed using Wave One Gold reciprocating file system as per manufacturer’s guidelines. This involves a reciprocating technique for bio mechanical preparation of the root canal. |
|
|
Inclusion Criteria
|
| Age From |
28.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 2 Diabetes mellitus for a minimum of 5 years and who are under medication with HbA1c under 7
Teeth with irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
Patients with complicated systemic diseases under medication for the same.
Patients who took medication for pain relief within 48 h before the start of treatment.
Patients having severe pain and/or apical abscess.
Patients having multiple teeth requiring treatment.
Patients with non restorable periodontally compromised teeth
Pregnant patients.
Teeth with calcified canals.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain intensity measured using visual analog scale to evaluate post operative tooth pain |
Pain will be assessed at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of Procedural Complications and Analgesic Consumption
|
Postoperative pain and other outcomes will be assessed at the following intervals after completion of the root canal treatment:
6 hours
12 hours
24 hours
48 hours
72 hours
One week |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
20/09/2025 |
| 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) |
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
|
This study aims to compare post-operative tooth pain after root canal treatment using two different endodontic file system - ProTaper Gold rotary file system and WaveOne Gold reciprocating file system in patients with controlled diabetes mellitus. Root canal therapy is commonly associated with post-operative pain, and this pain may vary depending on the instrumentation technique used. The study will evaluate post-operative pain intensity using a Visual Analogue Scale (VAS) at specific time intervals after the procedure (6 hours, 24 hours, 48 hours, 72 hours, and 7 days). Findings from this study may help in selecting the appropriate root canal technique to minimize pain in diabetic patients. |