| CTRI Number |
CTRI/2025/09/094144 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Two Rotary File Systems for Root Canal Treatment in Primary Molars in Children |
|
Scientific Title of Study
|
Evaluation and comparison of effectiveness of single file rotary system vs sequential multi-file
rotary system for pulpectomy in primary molars: an in vivo 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 Mehak Behal |
| Designation |
PG Resident |
| Affiliation |
Christian Dental College , Ludhiana |
| Address |
Room No. 8, Block-B, Department of Pedodontics and Preventive Dentistry, Christian Dental College, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
7986890616 |
| Fax |
|
| Email |
behalmehak18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaila |
| Designation |
Professor, Department of Pedodontics |
| Affiliation |
Christian Dental College , Ludhiana |
| Address |
Room No. 8, Block-B, Department of Pedodontics and Preventive Dentistry, Christian Dental College, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9872629087 |
| Fax |
|
| Email |
shaila224@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joe Mathew Cherian |
| Designation |
Associate Professor |
| Affiliation |
Christian Dental College, Ludhiana |
| Address |
Room No. 8, Block-B, Department of Pedodontics and Preventive Dentistry, Christian Dental College, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9501708436 |
| Fax |
|
| Email |
joemathewcherian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Dental College, Brown Road, Ludhiana, Punjab, India, 141008 |
|
|
Primary Sponsor
|
| Name |
Dr Mehak Behal |
| Address |
Christian Dental College, Brown Road, Ludhiana (141008) |
| Type of Sponsor |
Other [Self] |
|
|
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 Mehak Behal |
Christian Dental College |
Room no-8, Block-B, Department of Pedodontics and Preventive Dentistry
Ludhiana
PUNJAB |
7986890616
behalmehak18@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 |
| Comparator Agent |
Conventional Hand File System |
Pulpectomy will be performed using Kedo SH hand files.
|
| Intervention |
Sequential Multi-File Rotary System |
Pulpectomy in primary molars will be carried out using Kids-e-files , a multi sequetial NiTi rotary file system. Each tooth will be instrumented with only one rotary file according to the manufacturer’s protocol |
| Intervention |
Single File Rotary System |
Pulpectomy in primary molars will be carried out using Kedo nano plus, a single NiTi rotary file system. Each tooth will be instrumented with only one rotary file according to the manufacturer’s protocol |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Primary molars indicated for pulpectomy with chronic irreversible pulpitis or pulp necrosis.
Frankl behavior rating score 3 (Positive) or 4 (Definitely positive)
more than or equal to two-thirds of remaining root length on the selected tooth.
Written informed consent from parent or guardian (child assent where applicable) |
|
| ExclusionCriteria |
| Details |
Systemic disease (medically compromised patients)
Disruptive behaviour during the procedure
Frank dentoalveolar abscess or extra-oral swelling associated with the tooth
less than one-third pathologic root resorption of the involved primary molar |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Instrumentation time (in minutes)
2 Obturation time (in minutes)
3 Quality of obturation (voids and extent of fill assessed radiographically immediately after treatment) |
Instrumentation and obturation times – intra-operative (measured during pulpectomy); Quality of obturation – immediate post-operative (radiographic assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of baseline variables (age, gender, tooth type) on outcomes |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pulpectomy in primary molars is performed to retain the tooth in a symptom-free state until exfoliation, preserving arch integrity and function. Conventional hand instrumentation, though widely used, is time-consuming and may lead to procedural errors. Rotary systems, especially pediatric rotary files, have been introduced to improve efficiency and quality of root canal preparation.
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of a single file rotary system and a sequential multi-file rotary system with the conventional hand file system in pulpectomy of primary molars in children aged 4–9 years. Ninety primary molars diagnosed with irreversible pulpitis or pulp necrosis will be randomly allocated into three groups (n=30 each).
Primary outcomes will include instrumentation time (minutes), obturation time (minutes), and quality of obturation (radiographic assessment of voids and extent of fill). Secondary outcomes will assess the influence of baseline variables (age, gender, tooth type).
The study will provide evidence on whether pediatric rotary file systems improve clinical efficiency and obturation quality compared to conventional hand instrumentation, thereby contributing to better patient cooperation and treatment outcomes in pediatric endodontics. |