| CTRI Number |
CTRI/2026/01/102495 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare and evaluate the amount of penetration of radiopaque dye and reduction of pain after completion of root canal preparation using different types of root canal irrigants in root canal treatment. |
|
Scientific Title of Study
|
Comparative evaluation of apical depth penetration and postoperative pain using 9% 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) as continuous chelation and 5% glycolic acid, 10% glycolic acid,17% EDTA as sequential chelation using sonic irrigation technique in symptomatic vital teeth: A double blinded 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 Vineeta Nikhil |
| Designation |
Head of Department |
| Affiliation |
Subharti Dental College and Hospital/Swami Vivekanand Subharti University |
| Address |
Room no 8, third floor, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58 Delhi Haridwar by pass road Meerut
NH 58 Delhi Haridwar by pass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639002866 |
| Fax |
|
| Email |
endobyvineeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Nikhil |
| Designation |
Head of Department |
| Affiliation |
Subharti Dental College and Hospital/Swami Vivekanand Subharti University |
| Address |
Room no 8, third floor, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58 Delhi Haridwar by pass road Meerut
NH 58 Delhi Haridwar by pass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639002866 |
| Fax |
|
| Email |
endobyvineeta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineeta Nikhil |
| Designation |
Head of Department |
| Affiliation |
Subharti Dental College and Hospital/Swami Vivekanand Subharti University |
| Address |
Room no 8, third floor, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58 Delhi Haridwar by pass road Meerut
NH 58 Delhi Haridwar by pass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639002866 |
| Fax |
|
| Email |
endobyvineeta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College and Hospital, NH 58 bypass road, Meerut, India, 250005 |
|
|
Primary Sponsor
|
| Name |
Department of Conservative Dentistry and Endodontics |
| Address |
Room no 08, third floor, Subharti Dental College and Hospital, NH 58 bypass road, Meerut, Uttar Pradesh, 250005, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vineeta Nikhil |
Subharti Dental College and Hospital |
Room no 8, third floor, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, NH 58 bypass road, Meerut, 250005
Meerut
UTTAR PRADESH |
9639002866
endobyvineeta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethical Committee (Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10% glycolic acid will be used as root canal irrigant |
During root canal preparation along with NaOCl 10% glycolic acid will be used as root canal irrigant after each file |
| Comparator Agent |
5% glycolic acid will be used as root canal irrigant |
During root canal preparation along with NaOCl 5% glycolic acid will be used as root canal irrigant after each file |
| Comparator Agent |
9% 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) will be used as root canal irrigant |
During root canal preparation along with NaOCl, 9% 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) will be used as root canal irrigant after each file |
| Intervention |
Root canal irrigation with 17% EDTA |
During root canal preparation along with NaOCl, 17% EDTA will be used as a root canal irrigant after every file. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged between 18-40 years.
2. Adult permanent symptomatic anterior or
posterior teeth requiring treatment.
3. Pain at NRS scale above 4 cm level.
4. Feasibility of isolation of the tooth with
a rubber dam.
5. Participants with the ability to
understand the consent forms |
|
| ExclusionCriteria |
| Details |
1. Perforation cases
2. Periodontally compromised tooth.
3. Patients not willing for the treatment
4. Patients allergic to iodine.
5. Non-negotiable canals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the apical depth penetration using 9% HEDP in combination with Sodium hypochlorite (NaOCl), 5% glycolic acid, 10% glycolic acid, and 17% EDTA as sequential chelation using sonic irrigation technique in symptomatic vital teeth. |
After procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the post-operative pain using 9% HEDP in combination with Sodium hypochlorite (NaOCl), 5% glycolic acid, 10% glycolic acid, and 17% EDTA as sequential chelation using sonic irrigation technique in symptomatic vital teeth. |
Post operative pain will be checked after 6, 24 and 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="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 will compare four different irrigation protocols in root canal treatment to assess their effectiveness in irrigant penetration and post-operative pain. Patient selection Patients who will fulfil inclusion criteria will be randomly divided into four groups: Group 1: Sequential chelation with 2.5% NaOCl and 17% EDTA. Group 2: Sequential chelation with 2.5% NaOCl and 5% Glycolic acid. Group 3: Sequential chelation with 2.5% NaOCl and 10% Glycolic acid. Group 4: Continuous chelation with 9% HEDP + 2.5% NaOCl. Root canal procedure: Patients will be anesthetized, isolated with a rubber dam, and canals will be accessed and prepared with ProTaper Gold instruments. All four groups will receive irrigation after each file according to their respective group. Irrigant penetration evaluation: After final irrigation, 1 ml of radio-opaque dye will be injected into the canal and a radiograph will be taken to evaluate the irrigant penetration. Post-operative procedure: After drying the canals, the tooth will be temporarily sealed, and patients will return for obturation and post-operative restoration. Pain evaluation: Post-operative pain is recorded at 6, 24, and 48 hours using the NRS pain scale. If pain persists, patients will be prescribed an escape drug and excluded from the study. This study aims to determine which irrigation method provides better irrigant penetration and reduces post-operative pain. |