| CTRI Number |
CTRI/2024/10/074685 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy of 2 electronic devices used to measure the working length during root canal procedures in patients teeth with infection |
|
Scientific Title of Study
|
An in-vivo comparative evaluation of the accuracy of working length determination of two different apex locators in teeth with periapical lesion |
| 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 R Anithakumari |
| Designation |
Professor and HOD |
| Affiliation |
VS DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
VS DENTAL COLLEGE KR ROAD BANGALORE
Bangalore
KARNATAKA
560004
India |
| Phone |
9845919324 |
| Fax |
|
| Email |
Anithamanasi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Anithakumari |
| Designation |
Professor and HOD |
| Affiliation |
VS DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
VS DENTAL COLLEGE KR ROAD BANGALORE
Bangalore
KARNATAKA
560004
India |
| Phone |
9845919324 |
| Fax |
|
| Email |
Anithamanasi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Anithakumari |
| Designation |
Professor and HOD |
| Affiliation |
VS DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
VS DENTAL COLLEGE KR ROAD BANGALORE
Bangalore
KARNATAKA
560004
India |
| Phone |
9845919324 |
| Fax |
|
| Email |
Anithamanasi22@gmail.com |
|
|
Source of Monetary or Material Support
|
| VS Dental College KR Road Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Ashel Olivia Dsouza |
| Address |
VS DENTAL COLLEGE KR ROAD BANGALORE 560004 |
| 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 |
| ASHEL OLIVIA DSOUZA |
VS DENTAL COLLEGE AND HOSPITAL |
ROOM NO 6 DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS KR ROAD BANGALORE 560004
Bangalore
KARNATAKA |
9886407296
ashelds04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kempegowda Institute Of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)15 single rooted, single canal premolar teeth with radiographic evidence of periapical lesion.
2)15 single rooted, single canal premolar teeth indicated for root canal treatment without lesion |
|
| ExclusionCriteria |
| Details |
1)Patients with debilitating diseases
2)Immature root apex
3)Calcified canals
4)Internal and external root resorptions
5)Retreatment cases
6)Fractured or mutilated teeth
7)Curved canals greater than 30 degree
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| sucessful endodontic treatment |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/10/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a clinical observational study where 2 different generations of apex locators are evaluated and compared in patients with teeth with periapical lesion and without periapical lesion during root canal treatment. The primary outcome is to evaluate the accuracy and precision of these apex locators which will help in successful endodontic treatment. |