| CTRI Number |
CTRI/2025/02/080280 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study will be done to check the effect of intraosseous anesthesia to numb the tooth pain using normal method and dynamic navigation system |
|
Scientific Title of Study
|
Comparison of Intraosseous anesthesia using Free Hand Method and Dynamic Navigation System on Mandibular Molars with Symptomatic irreversible pulpitis : A Randomized Clinical 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 Vivek Hegde |
| Designation |
Professor and HOD Department of Conservative Dentistry and Endodontics |
| Affiliation |
M A Rangoonwala Dental College and Hospital |
| Address |
Room No 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Afrin D Mahimkar |
| Designation |
PG Student |
| Affiliation |
M A Rangoonwala Dental College and Hospital |
| Address |
Room no. 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983347429 |
| Fax |
|
| Email |
afrinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afrin D Mahimkar |
| Designation |
PG Student |
| Affiliation |
M A Rangoonwala Dental College and Hospital |
| Address |
Room no. 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983347429 |
| Fax |
|
| Email |
afrinendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune- 411001
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Hegde |
| Address |
Room no. 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune-411001
Maharashtra
India |
| 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 Vivek Hegde |
M A Rangoonwala Dental College and Hospital |
Room No 305
Department of
Conservative Dentistry
and Endodontics Azam
Campus 2390 KB
Hidayatullah Road
Camp Pune
Maharashtra
Pune
MAHARASHTRA |
9822055434
drvivekhegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCE Societys M A Rangoonwala Dental College Ethics Committee |
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 |
| Intervention |
Dynamic Navigation System |
Pre-operative CBCT will be taken.Intraosseous anesthesia will be given using Dynamic Navigation system. And post-operative CBCT will be taken to check the accuracy. |
| Comparator Agent |
Free Hand Method |
Pre-opearative CBCT will be taken to plan the path. Intraosseous anesthesia will be given using free hand method. Immediately post-operative CBCT will be taken to check the accuracy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to provide written informed consent.
Patients with symptomatic irreversible pulpitis involving mandibular molars with PAI score of less than or equal to 3. (Ostravik Classification)
Patients between 18-55 years of age.
Absence of systemic disease.
Confirmation of pulp vitality using thermal and electrical tests.
|
|
| ExclusionCriteria |
| Details |
•Periodontally compromised teeth with mobility and recession.
•Patients with swelling and sinus tract..
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the accuracy of intraosseous anesthesia using free hand method and dynamic navigation system on mandibular molars with symptomatic irreversible pulpitis. |
Pre-operative and post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare pain after administration intraosseous anesthesia using free hand method & dynamic navigation system on mandibular molars with symptomatic irreversible pulpitis. |
Pre-operative & post-operative |
|
|
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 4 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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
|
Profound pulpal
anesthesia is critical for effective pain control and patient management as
well as to minimize operator stress during endodontic treatment. Mandibular
teeth diagnosed with symptomatic irreversible pulpitis or “hot†tooth receiving
inferior alveolar nerve block showed low success rate in providing pulpal
anesthesia. Intraosseous
anesthesia is the only supplemental technique that has reported a predictable
success rate of 91%. However, the perceived difficulty in the precise
orientation of the drill tip may influence decision making of endodontists to
choose the significantly less effective supplementary PDL ligament injection
over the technique-sensitive intraosseous method. Patients will be randomly allocated into 2 groups (N=30)
Group 1: Intraosseous injection using
Free Hand Method (n=15)
Group 2:
Intraosseous injection using Dynamic Navigation System (n=15) |