| CTRI Number |
CTRI/2026/03/106952 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Evaluation of Hand and Rotary Files on Instrumentation Time and Postoperative Pain Following Pulpectomy in Primary Mandibular Molars of Children Aged 4–8 Years: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative evaluation of Pro AF Baby Gold files, Kids E files (Rainbow NiTi), and hand K-files (NiTi Flex) on instrumentation time and postoperative pain following pulpectomy in primary mandibular molars of children aged 4 to 8 years: 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 |
DHANASHRI SATISH HOLEY |
| Designation |
Post Graduate Student |
| Affiliation |
swargiya Dadasaheb Kalmegh Dental College and Hospital |
| Address |
Second floor,202,Department of Pediatric and Preventive Dentistry,
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,
Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07028280803 |
| Fax |
|
| Email |
holeydhanashri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunkumar Sajjanar |
| Designation |
Professor and Head |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Second floor,202, Department of Pediatric and Preventive Dentistry,
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,
Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9146768016 |
| Fax |
|
| Email |
arunsajju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DHANASHRI SATISH HOLEY |
| Designation |
Post Graduate Student |
| Affiliation |
swargiya Dadasaheb Kalmegh Dental College and Hospital |
| Address |
Second floor,202,Department of Pediatric and Preventive Dentistry,
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07028280803 |
| Fax |
|
| Email |
holeydhanashri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhanashri Holey |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur - 441110,
Maharashtra, India |
| Type of Sponsor |
Other [] |
|
|
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 |
| DHANASHRI SATISH HOLEY |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur |
Second floor,202,Department of Pediatric and Preventive Dentistry Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna, Nagpur
Nagpur
MAHARASHTRA |
07028280803
holeydhanashri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Swargiya Dadasaheb kalmegh Smruti Dental College and Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I: Hand K-files (NITI flex) (15-30k size) |
Group I: Hand K-files (NITI flex) (15-30k size) hand instrumentation |
| Intervention |
Group II: - (Pro AF baby gold files) (Dentalyze)
Group III: - (Kids e files, rainbow Niti ) (Kids-e-dental) |
rotary files |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1 Primary mandibular molars with irreversible pulpitis or with non-vital pulp
2. Children with no history of analgesic usage within 12 hours prior to the
procedure
3. The child should be in good health with no history of major systemic illness or
allergies.
4. Patient should be between 4 and 8 years of age.
5. Patients exhibiting Frankl’s behavior rating scale score of 3 (positive (+)) and 4
definitely positive (++).
6. Absence of internal or cervical pathologic root resorption.
7. A minimum of two-thirds of the remaining root length
8. A tooth structure strong enough to hold a rubber dam.
9. Co-operative children and parents willing to follow the instructions and report
for follow-up |
|
| ExclusionCriteria |
| Details |
1.Children with systemic illness such as congenital or rheumatic heart disease,
hepatitis, and leukemia etc.
2. Clinically, mobile tooth, discolored tooth, and a tooth with sinus opening,
fistula, or abscess.
3. Children lacking the cooperative ability.
4. Teeth with internal or external root resorption.
5. Teeth exhibiting pulpal floor perforation.
6. Radiolucent area in the furcation or peri radicular region
7. Patient/guardian not ready to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to compare instrumentation time and postoperative pain during pulpectomy in primary mandibular molars of children aged 4–8 years using three file systems: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files, with pain assessed up to one week using a four-point Verbal Rating Scale. |
At baseline till seventy two hpurs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
07/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This randomized clinical study will include 75 primary mandibular molars in children aged 4–8 years, divided into three groups based on instrumentation technique: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files (Rainbow NiTi). Pulpectomy will be performed using standard procedures including cleaning, shaping, disinfection, and obturation with a resorbable material. Instrumentation time will be recorded using a digital stopwatch from the start to completion of canal preparation. Postoperative pain will be evaluated at 6, 24, and 72 hours, and at 1 week using a four-point Verbal Rating Scale. Parents or caregivers will be trained to record pain scores |