| CTRI Number |
CTRI/2024/02/062813 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of accuracy of three different apex locators under clinical conditions. |
|
Scientific Title of Study
|
Comparative evaluation of the accuracy of Root ZX mini, Canal Pro Compact and EPex Pro apex locators under clinical conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Nandal |
| Designation |
Post graduate student |
| Affiliation |
JCD dental college |
| Address |
room no. 7 department of conservative and endodontics JCD dental college, barnala road sirsa
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
sheetalnandal.567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rakesh Singla |
| Designation |
Head of department |
| Affiliation |
JCD dental college |
| Address |
room no. 7 department of conservative and endodontics JCD dental college, barnala road sirsa
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
singlaendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal Nandal |
| Designation |
Post graduate student |
| Affiliation |
JCD dental college |
| Address |
room no. 7 department of conservative and endodontics JCD dental college, barnala road sirsa
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
sheetalnandal.567@gmail.com |
|
|
Source of Monetary or Material Support
|
| JCD dental college, barnala road, sirsa, haryana |
|
|
Primary Sponsor
|
| Name |
JCD dental college barnala road sirsa haryana |
| Address |
Department of conservative and endodontics, JCD dental college, barnala road, sirsa, haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sheetal nandal |
JCD dental college, barnala road, sirsa, haryana |
Room no. 7, Department of conservative and endodontics, JCD dental college, barnala road, sirsa, haryana
Sirsa
HARYANA |
9466671007
sheetalnandal.567@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Healthy Human Volunteers |
Advised for orthodontic extraction |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
electronic apical length measurement by Canal Pro Compact and Epex Pro |
calculation of electronic apical length after access opening in single rooted premolars advised for orthodontic extraction |
| Intervention |
electronic apical length measurement by Root ZX mini |
calculation of electronic apical length after access opening in single rooted premolars advised for orthodontic extraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
- patient of single root /single canal as confirmed by radiograph
- patient is in good health and not taking any medications
- patient response to cold sensitivity |
|
| ExclusionCriteria |
| Details |
- patients having more than one root/canal in premolar
- patient unable to give informed consent
medically compromised patients
- patients allergic to local anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| electric working length evaluation upto apex locators-root zx mini, canal pro compact and epex pro |
after access opening
after extraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| accuracy of apex locators- root zx mini, canal pro compact and epex pro |
comparison of working lengths determined by different apex locators |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
24/03/2024 |
| 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) |
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
|
Evaluation of accuracy of different types of apex locators (Root ZX mini, Canal Pro Compact and Epex Pro) in determining the electronic working length in patients advised for orthodontic extractions. Access opening is done in single rooted premolars advised for orthodontic extraction and working length is recorded with the help of three different apex locators then the tooth is extracted under local anaesthesia. Then actual working length is recorded under microscope. The electronic working length determined by different apex locators is compared with the actual working length to calculate the accuracy of recently developed apex locators - Canal Pro Compact and Epex Pro with the Root ZX mini apex locator |