| CTRI Number |
CTRI/2026/01/100158 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Precision and validity of newer apex locator in primary molars. |
|
Scientific Title of Study
|
Propex pixi vs dpex v apex locator: precision clinical utility and validity in pediatric endodontics |
| 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 Jina Milinkumar Jani |
| Designation |
Associate Professor |
| Affiliation |
Gujarat University |
| Address |
Department of pediatric and Preventive Dentistry, Collwgw of dental Sciences and research center, Ahmedabad
Department of pediatric and Preventive Dentistry, Collwgw of dental Sciences and research center, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9924857457 |
| Fax |
|
| Email |
jinajani15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Panda |
| Designation |
Phd Guide |
| Affiliation |
College of dental sciences and research center |
| Address |
Department of Pediatric and Preventive Dentistry
Manipur
Ahmadabad
GUJARAT
380058
India |
| Phone |
9820900015 |
| Fax |
|
| Email |
dranuppanda76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jina Milinkumar Jani |
| Designation |
Associate Professor |
| Affiliation |
College of dental sciences and research center |
| Address |
Department of pediatric and preventive dentistry
Manipur
Ahmadabad
GUJARAT
380058
India |
| Phone |
9924857457 |
| Fax |
|
| Email |
jinajani15@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of dental sciences and research center, Ahmedabad, gujarat, India 380058 |
|
|
Primary Sponsor
|
| Name |
Dr Jina Jani |
| Address |
College of dental sciences and research center |
| Type of Sponsor |
Research institution |
|
|
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 Jina Milinkumar Jani |
college of dental sciences and research center |
Department of Pediatric and preventive Dentistry
Ahmadabad
GUJARAT |
09924857457
jinajani15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC College of Dental Sciences and research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
na |
na |
| Intervention |
na |
na |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular primary molars
requiring pulpectomy with at least two-thirds of the root remaining
Children demonstrating positive or definitely positive behavior on
Frankls behavior rating scale Teeth assessed clinically and
radiographically as restorable |
|
| ExclusionCriteria |
| Details |
Children with systemic diseases or special health care
needs Teeth with significant periapical furcation radiolucency
pathological mobility or nonrestorable crowns Cases with previously
initiated endodontic treatment. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| positive correlation is expected among all three comparisons |
positive correlation is expected among all three comparisons |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
09/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
To evaluate the accuracy of the new 6th generation apex locator DPEX V with Propex Pixi and Digital Radiography for determining Working Length (WL) in primary mandibular molars. Digital radiography (DR) Propex Pixi and DTE DPEX-V Apex Locators were employed for determining WL of total of 36 primary mandibular molars. Following collection, data were compiled, and statistical analysis was performed on the findings |