| CTRI Number |
CTRI/2025/04/085546 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF PAIN AFTER ROOT CANAL TREATMENT USING ENDOMOTOR WITH INBUILT APEX LOCATOR - A RANDOMIZED CLINICAL TRIAL |
|
Scientific Title of Study
|
COMPARISON OF POST OPERATIVE PAIN AND ACCURACY OF WORKING LENGTH DETERMINATION USING ENDOMOTOR WITH INBUILT APEX LOCATOR AND ENDOMOTOR WITHOUT APEX LOCATOR- A RANDOMIZED CLINICAL TRIAL |
| Trial Acronym |
Randomized clinical trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Arulalan (POST GRADUATE) |
| Designation |
|
| Affiliation |
|
| Address |
ROOM NO 9
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL
MADURAVOYAL, ALAPAKKAM MAIN ROAD
CHENNAI
ROOM NO 9
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL
MADURAVOYAL, ALAPAKKAM MAIN ROAD
CHENNAI
Chennai
TAMIL NADU
600095
India |
| Phone |
09677352806 |
| Fax |
|
| Email |
monika.arulalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SATHISH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
|
| Address |
ROOM NO 9
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL
MADURAVOYAL, ALAPAKKAM MAIN ROAD
CHENNAI
289/A BALAJI NAGAR PARAMATHY VELUR NAMAKKAL
Namakkal
TAMIL NADU
600095
India |
| Phone |
09677352806 |
| Fax |
|
| Email |
sathishsundar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VELMURUGAN |
| Designation |
HOD |
| Affiliation |
MAHER |
| Address |
ROOM NO 9
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL
MADURAVOYAL, ALAPAKKAM MAIN ROAD
CHENNAI
Chennai
TAMIL NADU
600095
India |
| Phone |
09677352806 |
| Fax |
|
| Email |
velu9911@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Monika CA |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095 |
| Type of Sponsor |
Other [Self Funded Thesis] |
|
|
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 |
| Monika CA |
MAHER |
ROOM NO 9 department of conservative dentistry and endodontics
Meenakshi Ammal Dental College , Alapakkam Main Road, Maduravoyal, Chennai - 600095
Chennai
TAMIL NADU |
9677352806
monika.arulalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ages ranging from : 18-65 years
Systemically healthy individuals (ASA class 1)
Human permanent maxillary and mandibular first and second molars and premolars.
Patients diagnosed with symptomatic and asymptomatic irreversible pulpitis
VAS score (mild) to (moderate)(1-4)
|
|
| ExclusionCriteria |
| Details |
Non-vital teeth, swelling, sinus tract
endodontic retreatment
root resorption, cracks , trauma
immature / open apex
patients with any uncontrolled systemic disease.
tooth with multiple wall defects.
patients with severe pain, tooth with PAI >2
periodontally compromised teeth
pregnancy and lactating mother.
Aberrant root canal anatomy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study outcome helps the clinician to decide on an better efficacy and accuracy in cleaning and shaping root canals so that the post operative endodontic pain can be minimized |
1 hour , 24 hours,48 hours 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Accuracy of Working Length |
Will be measured before initiation of biomechanical preparation |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
22/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/05/2025 |
| 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 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
|
Patients were randomly divided into two groups after fulfilling the inclusion and exclusion criteria. Access opening was done . Working length was determined using electronic apex locator mode in both the groups. GROUP 1 - Canal pro CL2i and GROUP 2 - AI Endomotor . Biomechanical preparation was done. Obturation was done. Post operative pain was assessed at the time interval of 4 ,8,12, 48 hours. |