| CTRI Number |
CTRI/2024/04/065858 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical Study comparing the two guided root canal treatment techniques to negotiate the calcified maxillary anterior teeth |
|
Scientific Title of Study
|
Comparative evaluation of Static and Dynamic Navigation in management of calcified maxillary anterior teeth: A Randomized Control Trial |
| 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 Srilatha S |
| Designation |
Professor, Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A.Rangoonwala Dental College and Research Centre |
| Address |
Room Number 305 Department of Conservative Dentistry and
EndodonticsM. A. Rangoonwala Denal College and Hospital Azam
Campus 2390 B K B Hidayatullah Road Camp Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9049397929 |
| Fax |
|
| Email |
drsri2005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srilatha S |
| Designation |
Professor, Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A.Rangoonwala Dental College and Research Centre |
| Address |
Room Number 305 Department of Conservative Dentistry and
EndodonticsM. A. Rangoonwala Denal College and Hospital Azam
Campus 2390 B K B Hidayatullah Road Camp Pune
MAHARASHTRA
411001
India |
| Phone |
9049397929 |
| Fax |
|
| Email |
drsri2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srilatha S |
| Designation |
Professor, Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A.Rangoonwala Dental College and Research Centre |
| Address |
Room Number 305 Department of Conservative Dentistry and
EndodonticsM. A. Rangoonwala Denal College and Hospital Azam
Campus 2390 B K B Hidayatullah Road Camp Pune
MAHARASHTRA
411001
India |
| Phone |
9049397929 |
| Fax |
|
| Email |
drsri2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A. Rangoonwala Dental College & HospitalRoom Number 305 Department of Conservative
Dentistry and Endodontics Azam Campus 2390 B K B Hidayatullah Road Camp |
|
|
Primary Sponsor
|
| Name |
Dr Srilatha S |
| Address |
M. A. Rangoonwala Denal College and Hospital Azam Campus 2390
B K B Hidayatullah Road Camp |
| 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 Srilatha S |
M. A. Rangoonwala Denal College and Hospital |
Room number 305
Department of
Conservative Dentistry
and Endodontics Azam
Campus 2930 B K B
Hidayatullah road
Camp
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9049397929
drsri2005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K043||Abnormal hard tissue formation inpulp, (2) ICD-10 Condition: K043||Abnormal hard tissue formation inpulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional root canal treatment |
Nonsurgical root canal treatment is performed to negotiate without the static or dynamic navigation followed by evaluation of time taken, substance loss, angle of deviation immediately with post op cbct
The patients will be checked clinically and radiographically at 3months, 6months and 12 months |
| Intervention |
Dynamic Guided Navigation |
Nonsurgical root canal treatment is performed with the real time guided navigation to negotiate the calcified canal followed by evaluation of time taken, substance loss, angle of deviation immediately with post op cbct
The patients will be checked clinically and radiographically at 3months, 6months and 12 months |
| Intervention |
Static Guided Navigation |
Nonsurgical root canal treatment is performed with the static guide to negotiate the calcified canal.
The evaluation of time taken, substance loss, angle of deviation immediately with post op cbct
The patients will be checked clinically and radiographically at 3months, 6months and 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with pulp space obliteration in maxillary anterior teeth.
Teeth with Periapical Index less than or equal to 3
A surgical intervention not justified
Patient willing to give consent |
|
| ExclusionCriteria |
| Details |
Teeth with fractures
Teeth with immature apices
Teeth with periodontal involvement (Endo - Perio)
Patients with any systemic diseases
Teeth with mobility class II or greater
Poor restorability
Neighbouring teeth with metal restorations leading to CBCT artefacts |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the substance loss, angle of deviation and time taken between conventional, static and dynamic navigation in management of calcified maxillary anterior teeth. |
Immediately after the treatment the post operative cbct will be evaluated.
Time taken to negotiate the canal would be recorded using stop watch |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Treatment outcome, both clinical and radiological would be assessed |
1, 3 and 6months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="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
|
To assess and compare the effectiveness of static and dynamic navigation techniques in managing calcified maxillary anterior teeth, potentially informing improbements in treatment protocols for such cases |