| CTRI Number |
CTRI/2025/12/099755 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To test whether New Cleaning Methods can Reduce Pain After a Second Root Canal Treatment? |
|
Scientific Title of Study
|
Influence of Irrigant Activation Techniques on Post-Operative Pain Following Root Canal Retreatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saee Anawalikar |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09922956700 |
| Fax |
|
| Email |
drsaeeanawalikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Solete |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9710404482 |
| Fax |
|
| Email |
pradeeps@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Solete |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9710404482 |
| Fax |
|
| Email |
pradeeps@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, 162, Poonamallee High Road, Chennai 600077,Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Saee Anawalikar |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital, 162 Poonamallee High Rd, Chennai |
| Type of Sponsor |
Private medical college |
|
|
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 Saee Anawalikar |
Saveetha Dental Hospital |
Department of Conservative Dentistry and Endodontics, Clinic 21, Chennai 600077
Chennai
TAMIL NADU |
09922956700
drsaeeanawalikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyflex Remover retreatment with conventional needle irrigation or sonic activation |
Hyflex Remover retreatment file will be used for removing the old root canal filling material and disinfection will be done using conventional needle irrigation for one subgroup and for the other subgroup sonic activation will be used for one of the subgroup |
| Intervention |
Solite RE Black retreatment file with conventional irrigation or sonic activation |
Solite RE Black retreatment file will be used for removing the root canal filling material and disinfection will be done using conventional needle irrigation for one subgroup and for the other subgroup sonic activation will be done using sonic activatior |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having pain and requiring re root canal treatment.
Individuals without any systemic illness |
|
| ExclusionCriteria |
| Details |
Individuals with systemic diseases.
Teeth indicated for extraction where re root canal treatment is not possible |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain reduction |
Post operative pain reduction preoparitvely at 6hrs, 24hrs, 48hrs, 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="2"
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
|
Post operative pain is a common challenge following root canal retreatment and maybe influenced by both various irrigant activation techniques used and various preoperative factors. This study aims to evaluate the impact of different irrigant activation techniques (sonic and ultrasonic irrigation techniques) used with 2 different file systems on postoperative pain and to determine how preoperative periapical lesions, missed canals, root canal filling density, root canal filling length, coronal restoration quality will modify pain outcomes. Patients undergoing non surgical retreatment will be assigned to various irrigant activation techniques and pain will be assesed preoperatively at 6 hrs, 24hrs, 48hrs and 7 days. |