| CTRI Number |
CTRI/2025/09/095433 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Root canal treatment in primary teeth comparing different file systems |
|
Scientific Title of Study
|
Comparative evaluation of Biomechanical preparation time and obturation quality using hand files and rotatory file system in pulpectomy: An Invivo study |
| 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. Aarya Jain |
| Designation |
PG student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
B 12 Kucheni parisar damohnaka Jabalpur
Room no 8
Ground floor
Pediatric and preventive dentistry
Hitkarini dental college and hospital
Hitkarini hills dumna road jabalpur
Jabalpur
MADHYA PRADESH
482002
India |
| Phone |
8305973738 |
| Fax |
|
| Email |
jainaarya27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debapriya Pradhan |
| Designation |
Head Of The Department |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
A 401
Aakarsh paradise society
Bilhari
Room no 8
Ground floor
Pediatric and preventive dentistry
Hitkarini dental college and hospital
Hitkarini hills dumna road jabalpur
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
96199211116 |
| Fax |
|
| Email |
pradhandp@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Aarya Jain |
| Designation |
PG student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
B 12 Kucheni parsidar damohnaka jabalpur
Ground floor
Pediatric and preventive dentistry
Hitkarini dental college and hospital
Hitkarini hills dumna road jabalpur
Jabalpur
MADHYA PRADESH
482002
India |
| Phone |
8305973738 |
| Fax |
|
| Email |
jainaarya27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hitkarini Dental College And Hospital
room no 8
Ground floor
department of Pediatric and preventive dentistry
Hitkarini hills dumna road jabalpur madhya pradesh
482001
india
|
|
|
Primary Sponsor
|
| Name |
Hitkarini Dental College and Hospital |
| Address |
Room no 8
Ground floor
Pediatric and preventive dentistry
Hitkarini dental college and hospital
Hitkarini hills dumna road jabalpur
|
| 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 Aarya Jain |
Hitkarini dental college and hospital |
Room no 8
Ground floor
Department of pediatric and preventive dentistry
Hitkarini dental college and hospital
Hitkarini Hills dumna road jabalpur
Jabalpur
MADHYA PRADESH |
8305973738
jainaarya27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo nano plus rotary file system |
pediatric single file system for pulpectomy in primary molar and observed immediately after obturation |
| Intervention |
kedo SG blue rotary file system |
double file system for the pulpectomy treatment of primary molar and observed immediately after obturation |
| Intervention |
neoendo pedoflex rotary file system |
using three file system in pulpectomy for the treatment of primary molar |
| Comparator Agent |
NiTi K flex hand file system |
using hand file system for the pulpectomy of the primary molar and observed immediately after obturation |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with definitely positive or positive according to frankl behaviour rating scale.
Healthy children from 4 to 12 years of age who are willing to participate in the study.
Patient with symptomatic carious lesion with dentin and pulp involvement, verified by radiographic examination.
Carious lesion with pulpal involvement.
Teeth with no radiographic signs of internal and external resorption.
No furcation radiolucency.
|
|
| ExclusionCriteria |
| Details |
1. Non-consent of parent to participate in
the study.
2. Uncooperative patient.
3. Deep carious lesion with no pulpal
involvement.
4. Medically compromised children.
5. Tooth with restoration or fracture.
6. Mobility should be absent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence/absence of voids and level of filling |
At Baseline |
|
|
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)
|
08/10/2025 |
| 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 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
|
The study aims to clinically compare the time required for biomechanical preparation (TBMP) and the quality of root canal obturation to see the canal preparation presence/absence of void and using hand files and level of filling three rotary file systems (single, double, and triple systems) in primary molars |