| CTRI Number |
CTRI/2024/06/069219 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing How Well an Electronic Apex Locator and Special X-rays Determine Root Canal Length in Childrens Lower Molars with and without Root Damage |
|
Scientific Title of Study
|
Evaluating the Specificity and Sensitivity of Electronic Apex Locator Compared to Photostimulable Phosphor Radiographs for Establishing the Working Length in Pulpectomy of Primary Mandibular Second Molar With and Without Root Resorption – 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 B Bhanu Teja |
| Designation |
First Year Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no-5,Department of Pediatric and Preventive Dentistry ,JSS Dental college ,Bannimantap ,mysore,570015
Mysore
KARNATAKA
570015
India |
| Phone |
9502337553 |
| Fax |
|
| Email |
bhanutejab1125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brinda Suhas Godhi |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no-5,Department of Pediatric and Preventive Dentistry ,JSS Dental college ,Bannimantap ,mysore,570015
Mysore
KARNATAKA
570015
India |
| Phone |
7259749417 |
| Fax |
|
| Email |
dr.brindasgodhi@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Bhanu Teja |
| Designation |
First Year Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no-5,Department of Pediatric and Preventive Dentistry ,JSS Dental college ,Bannimantap ,mysore,570015
Mysore
KARNATAKA
570015
India |
| Phone |
9502337553 |
| Fax |
|
| Email |
bhanutejab1125@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital,Bannimantap,Mysuru,Karnataka 570015 |
|
|
Primary Sponsor
|
| Name |
JSSAHER |
| Address |
Room no 5,Department of Pediatric and Preventive Dentistry,JSS Dental College and Hospital, Bannimantap,Mysore,570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr B Bhanu Teja |
Room no 5,Department of Pediatric and Preventive Dentistry,JSS Dental College and Hospital, Bannimantap,Mysore,570015 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Bhanu Teja |
JSS Dental College and Hospital |
Room no 5,Department of Pediatric and Preventive Dentistry,JSS Dental College and Hospital,Bannimantap,Mysore 570015
Mysore
KARNATAKA |
09502337553
bhanutejab1125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age 4-9 years with primary mandibular second molars.
2.Children from both the sexes.
3.Primary mandibular second molars, with three canals and more than two third of the root length remaining radiographically.
4.Primary mandibular second molars with irreversible pulpitis, necrotic pulp indicated for pulpectomy
|
|
| ExclusionCriteria |
| Details |
1.Children with underlying systemic conditions, immunocompromised and special health care needs.
2.Primary mandibular second molars with mobility, vertical root fracture.
3.Tooth which are non-restorable, with more than two third of root length is resorbed.
4.Children undergoing orthodontic treatment
5.Uncooperative patients (Frankl scale 1 and 2)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To evaluate the accuracy of PSP radiograph in determining the working length in primary mandibular second molars with and without resorption |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the accuracy of ROOT ZX II apex locator in determining the working length in primary mandibular second molars with and without resorption
2.To compare the efficacy of ROOT ZX II with PSP radiograph in determining working length in primary mandibular second molars with and without resorption
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/07/2024 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Bhanutejab1125@gmail.com].
- For how long will this data be available start date provided 20-06-2024 and end date provided 08-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The working length has been determined by using
convention radiograph and digital radiographs RVG. Compared to conventional
radiographs RVG has certain advantages, which include an instantaneous display
of the image on a viewing screen that eliminates the time and equipment required
for film processing and also provides an additional ability to alter the
displayed image that enhances the capability to identify details. The RVG image
may be altered by varying the contrast in the grayscale, by reversal of the
black and white aspects of the image (negative-to-positive conversion), and by
selectively enlarging the screen image (the zoom feature)
Presently digital radiographs with photostimulable storage phosphor
(PSP) plates have been widely used in clinical practice owing to their
convenience and lower radiation dose compared to conventional radiographs.
Among the currently used digital receptors, flexibility of PSP is considered an
advantage compared to charge-coupled devices (CCD) and also image
quality is very good both in low and high doses at PSP.The purpose is to assess the specificity and sensitivity of the EAL
(Electronic Apex Locator, Root ZX II) compared to Digital PSP radiographs in
determining the accurate length of root canals in primary mandibular second
molars with and without resorption. Determining accurate root canal length is
an important part of successful root canal therapy in primary teeth in order to
minimize periapical injury and possible damage to succedaneous teeth. The
accurate root canal length of primary teeth is difficult to predict because of
the pattern of root resorption, which is either a physiological process in the
lifespan of primary teeth or a pathological outcome due to periapical pathosis.
The size, shape, and position of the root apices of primary teeth show
continuous alteration. For this reason, it becomes difficult to accurately
determine the root canal length of primary teeth. Therefore, one of the main
concerns in the root canal treatment of primary teeth is to determine how far
instruments should be advanced within the root canal and at what point the
preparation and filling should terminate. |