| CTRI Number |
CTRI/2025/03/083128 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate the depth of penetration and postoperative pain using various 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 17% EDTA AS SEQUENTIAL CHELATION USING SONIC IRRIGATION TECHNIQUE IN SYMPTOMATIC VITAL TEETH: 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 SHOHRAT IQBAL |
| Designation |
MDS (Post graduate) |
| Affiliation |
I.T.S DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
room no.7, department of conservative dentistry and Endodontics, I.T.S dental college hospital and research centre, greater noida 47, knowledge park-3
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9810976792 |
| Fax |
|
| Email |
shohrat.mds24@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANSI PUNJABI |
| Designation |
Professor |
| Affiliation |
I.T.S DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
room no.7, department of conservative dentistry and Endodontics, I.T.S dental college hospital and research centre, greater noida 47, knowledge park-3
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9999680116 |
| Fax |
|
| Email |
drmansipunjabi.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHOHRAT IQBAL |
| Designation |
MDS (POST GRADUATE) |
| Affiliation |
I.T.S DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
room no.7, department of conservative dentistry and Endodontics, I.T.S dental college hospital and research centre, greater noida 47, knowledge park-3
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9810976792 |
| Fax |
|
| Email |
shohrat.mds24@its.edu.in |
|
|
Source of Monetary or Material Support
|
| room no.7, department of conservative dentistry and Endodontics, I.T.S dental college hospital and research centre, greater noida 47, knowledge park-3, 201310 uttar pradesh, India |
|
|
Primary Sponsor
|
| Name |
Its Dental college hospital and research centre |
| Address |
room no.7, department of conservative dentistry and Endodontics, I.T.S dental college hospital and research centre, greater noida 47, knowledge park-3, 201310 uttar pradesh, 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 Shohrat Iqbal |
ITS Dental College Hospital and Research Centre Greater Noida |
room no 7 department of conservative dentistry and endodontics ITS dental college Hospital and research centre greater noida
Gautam Buddha Nagar
UTTAR PRADESH |
9810976792
shohrat.mds24@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS dental college Hospital and Research Centre INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
Dual rinse HEDP |
Dual rinse HEDP is used as continuous chelation that can be used as a single solution mixed with sodium hypochlorite in root canal treatment. It helps softens and dissolve the dentine and remove the smear layer. Hence it decreases the working time. |
| Comparator Agent |
EDTA 17% |
Chelating agents are used in endodontics to prepare root canals for treatment. They help to soften and dissolve the dentine in the root canal, and remove the smear layer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged between 18-30 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
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the apical depth penetration using 9% HEDP in combination with Sodium hypochlorite (NaOCl) with the standard irrigating protocol (17% EDTA + NaOCl) 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) with the standard irrigating protocol (17% EDTA + NaOCl) 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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 compares two different irrigation protocols in root canal treatment to assess their effectiveness in irrigant penetration and post-operative pain: Patient selection: Patients are diagnosed and randomly divided into two groups: Group 1: Sequential chelation with 2.5% NaOCl and 17% EDTA. Group 2: Continuous chelation with 9% HEDP + 2.5% NaOCl. Root canal procedure: Patients are anesthetized, isolated with a rubber dam, and canals are accessed and prepared with ProTaper Next instruments. Both groups receive irrigation after each file: Group 1 with NaOCl and EDTA, Group 2 with NaOCl and HEDP. Final irrigation steps differ between groups, with Group 1 using NaOCl and EDTA, and Group 2 using HEDP + NaOCl and saline. Irrigant penetration evaluation: After final irrigation, 1 ml of radio-opaque dye is injected into the canal and a radiograph is taken to evaluate the irrigant penetration. Post-operative procedure: After drying the canals, the tooth is temporarily sealed, and patients 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 are 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. |