| CTRI Number |
CTRI/2024/10/074825 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing working length in non vital teeth open tip using 2 different apex locators |
|
Scientific Title of Study
|
Comparitive working length determination of non-vital teeth with immature apices : 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 Anitha Kumari |
| Designation |
HOD and professor |
| Affiliation |
Vokkaligara Sangha dental college and hospital |
| Address |
Department of conservative dentistry and endodontics , VS dental college and hospital , next to KIMS hospital , KR Market road , basavanagudi bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9845919324 |
| Fax |
|
| Email |
anithamanasi18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANITHA KUMARI |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Vokkaligara Sangha dental college and hospital |
| Address |
Department of Conservative and Endodontics , VS dental college and hospital , next to KIMS hospital , Basavanagudi Bengaluru
KARNATAKA
560004
India |
| Phone |
9845919324 |
| Fax |
|
| Email |
anithamanasi18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerthana Shetty CM |
| Designation |
Postgraduate student |
| Affiliation |
Vokkaligara Sangha dental college and hospital |
| Address |
Department of conservative dentistry and endodontics , VS dental college and Hospital , Next to KIMS hospital , Basavanagudi, Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
903530509 |
| Fax |
|
| Email |
keerthana91135@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEERTHANA SHETTY CM
Department of conservative dentistry and endodontics VS dental college and hospital , Next to KIMS hospital , basanvanagudi Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Keerthana Shetty CM |
| Address |
Department of Conservative dentistry and endodontics , VS dental college , next to KIMS hospital , Basavanagudi , Bengaluru 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 |
| Dr Keerthana Shetty CM |
Vokkaligara Sangha Dental college and Hospital |
Room no 6, Department of Conservative Dentistry and Endodontics, Vokkaligara sangha dental college and Hospital , next to KIMS hospital , Basavanagudi, bengaluru
Bangalore
KARNATAKA |
9035360509
keerthana91135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kempegowda Institute of Medical Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient older than 14 years , Anterior teeth , Single canal , Single rooted teeth , teeth with open apex , immature and mature permanent teeth |
|
| ExclusionCriteria |
| Details |
Calcified teeth , Retreatment cases , Fractured teeth , curved canals more than 30 degree |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of working length determination by 2 apex locator in open apex cases |
Nil |
|
|
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
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/10/2024 |
| 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
|
A primary goal in root canal treatment is to reduce intra radicular microorganisms to a level below that necessary to induce or sustain apical periodontitis. An essential prerequisite is establishment of correct working length during root canal preparation, as failure to do so may result in accidental extrusion of irrigant, dressing or filling and persistent periapical inflammation and postoperative pain.The usual cause of endodontic involvement in a tooth with an incompletely developed root is trauma. Unfortunately, traumatic injuries to young permanent teeth are not uncommon; it is said that they affect 30% of children. The majority of these incidents occurs before root formation is complete, and may result in pulpal inflammation or necrosis. The term ‘open apex’ is used to indicate the presence of an exceptionally wide root canal at the apex. It is seen in immature teeth when root development ceases as a sequel of pulp necrosis due to trauma or caries. In mature apex extensive apical resorption, root end resection or over instrumentation may result in formation of open apex. The most favourable landmark to terminate the WL is the apical constriction. However, it is lost in cases of immature apex. Predictable assessment of WL has been possible with the invention of EAL.4 One of the major difficulties in performing endodontic treatment in a tooth with incomplete root formation is evaluating the working length. The missing apical constriction causes a high risk of initial over instrumentation. The purpose of this study is to evaluate the usefulness of electronic apex locator and integrated apex locator that are currently available in treatment of teeth with incomplete root formation. 2 As such only 2 studies comparing working length using apex locator in open apex case is present. There are not much studies present in literature. |