| CTRI Number |
CTRI/2026/01/101597 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain between dental visits when using two different root canal treatment methods of lower back teeth with infections. |
|
Scientific Title of Study
|
Comparison of inter-appointment pain using Proglider and Hyflex edm glide path files for root canal treatment in asymptomatic non-vital mandibular molars with periapical lesions : randomized clinical 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 Arpita Bhatia |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative Dentistry & Endodontics. Room No 3. J.N Kapoor DAV(c) Dental college
Model town Yamunanagar haryana.
135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9876724877 |
| Fax |
|
| Email |
arpitabhatia.13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bogra |
| Designation |
Professor and head of department |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative dentistry and endodontics. Room no 3.
J.N Kapoor DAV (c) dental college,Model town Yamunanagar haryana.
135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpita Bhatia |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative Dentistry and endodontics. Room no 3.
Model town Yamunanagar haryana.
135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9876724877 |
| Fax |
|
| Email |
arpitabhatia.13@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.N Kapoor Dav Dental College Model town,Yamunanagar, Haryana. India.
135001 |
|
|
Primary Sponsor
|
| Name |
J.N Kapoor Dav Dental College Yamunanagar |
| Address |
J.N Kapoor Dav Dental College Model town yamunanagar Haryana
135001 |
| Type of Sponsor |
Other [Private dental 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 Arpita Bhatia |
J.N Kapoor Dav Dental College Yamunanagar |
Department of conservative dentistry and endodontics. Room no 3
Yamunanagar
HARYANA |
9876724877
arpitabhatia.13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| J.N Kapoor Dav Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glide path file. |
HyFlex EDM (Coltene) |
| Intervention |
Glide path file. |
ProGlider (Dentsply) |
| Comparator Agent |
Proglider glide path file, HyFlex EDM glide path file |
ProGlider( Dentsply), HyFlex EDM |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group 18-65 years.
2. Healthy patients with ASAI and ASA II
3. Asymptomatic non-vital Mandibular molars.
4. Teeth with Periapical Index (PAI)less than equal to 3.
5. Teeth with periodontal probing less than or equal to 3mm.
6. Patients who had not taken any analgesic, antibiotic or antidepressant medication during 72 hours before treatment
7. Patients who agree with the informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Mandibular molars with pus or inflammatory exudates draining through the root canal or sinus tract.
2. Teeth with anatomical variations and internal /external resorption.
3. Previously initiated root canal treatment.
4. Teeth with symptomatic apical periodontitis.
5. Teeth with pathologic periodontal pockets during probing.
6. Patients who are hypersensitive to NSAIDS, antibiotics and immunosuppresants.
7. Pregnant and lactating mothers.
8. After negotiating canals, if the #15K-file crossed the apex without resistance of #08K-file could not reach the working length.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain
2) Swelling
3) Flare up index (FUI)
|
24 hours
48 hours
1 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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
|
RESEARCH QUESTIONS
1. Is
there any Inter-appointment pain/ swelling/analgesic intake when ProGlider glide path file is used during
endodontic treatment in asymptomatic non vital mandibular molars with
periapical lesions.
2. Is
there any Inter-appointment pain/ swelling/analgesic intake when HyFlex EDM glide path file is used during
endodontic treatment in asymptomatic non vital mandibular molars with
periapical lesions.
3. Is
there any difference in Inter-appointment pain/ swelling/analgesic intake when
ProGlider and HyFlex EDM glide path file is used during endodontic treatment in
asymptomatic non vital mandibular molars with periapical lesions. AIM:
To compare inter-appointment
pain using ProGlider and HyFlex EDM glide path files for root canal treatment
in Asymptomatic Non-Vital Mandibular Molars with periapical lesions.
OBJECTIVES:
1. To
evaluate Inter-appointment pain, analgesic intake, swelling and flare up index
with the use of ProGlider glide path file.
2. To
evaluate Inter-appointment pain, analgesic intake, swelling and flare up index
with the use of HyFlex EDM glide path file.
3. To
comparatively evaluate the above mentioned results.
|