| CTRI Number |
CTRI/2024/02/062781 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anesthetic Efficacy of Adjunt therapy with Inferior Alveolar Nerve Block in symptomatic irreversible pulpitis |
|
Scientific Title of Study
|
Anesthetic Efficacy of Adjunt therapy with Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Randomized Controlled 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 |
Sarika Kalantri |
| Designation |
Post Graduate student (MDS) |
| Affiliation |
Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute |
| Address |
Department of Conservative Dentistry and Endodontics, Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute, Parbhani, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
9405237252 |
| Fax |
|
| Email |
sarikaskalantri585@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaykumar L Shiraguppi |
| Designation |
Professor and Head of Department, Department Of Conservative Dentistry and Endodontics |
| Affiliation |
Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute |
| Address |
Department of Conservative Dentistry and Endodontics, Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute, Parbhani, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8329912617 |
| Fax |
|
| Email |
vlshiraguppi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarika Kalantri |
| Designation |
Post Graduate student (MDS) |
| Affiliation |
Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute |
| Address |
Department of Conservative Dentistry and Endodontics, Saraswati Dhanwantari Dental college and Hospital, Post graduate research institute, Parbhani, Maharashtra
Parbhani
MAHARASHTRA
431401
India |
| Phone |
9405237252 |
| Fax |
|
| Email |
sarikaskalantri585@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saraswati Dhanwantari Dental college and Hospital, Post graduate and research institute |
|
|
Primary Sponsor
|
| Name |
Saraswati Dhanwantari Dental college and Hospital Post graduate and research institute |
| Address |
Department of Conservative Dentistry and Endodontics, Saraswati Dhanwantari Dental college and Hospital, Post graduate and research institute, Parbhani, Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 Sarika Kalantri |
Saraswati Dhanwantari Dental college and Hospital, Post graduate and research institute |
Department of Conservative Dentistry and Endodontics, Saraswati Dhanwantari Dental college and Hospital, Post graduate and research institute, Parbhani, Maharashtra
Parbhani
MAHARASHTRA |
9405237252
sarikaskalantri585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saraswati Dhanwantari Dental College and Hospital, post graduate and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The subjects visiting dental college due to actively experiencing dental pain and in good health, and none will be taking any medication that would alter pain perception. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Inferior alveolar nerve block |
Conventional Inferior alveolar nerve block with 2% lignocaine Hydrochloride and 1:100000 adrenaline bitartrate will be administered for duration of 1 minute |
| Intervention |
Conventional Inferior alveolar nerve block plus cryotherapy |
Conventional Inferior alveolar nerve block with 2% lignocaine Hydrochloride and 1:100000 adrenaline bitartrate will be administered for duration of 1 minute each plus cryotherapy with Endo Frost (isobutane 10-20%, butane 30-50%, propane 30-50%) (ROEKO Endo Frost [Endo Frost], Coltene Whaledent for duration of 5 seconds. |
| Intervention |
Conventional Inferior alveolar nerve block plus local infiltration |
Conventional Inferior alveolar nerve block plus local infiltration on buccal surface with 2% lignocaine Hydrochloride and 1:100000 adrenaline bitartrate will be administered for duration of 1 minute each |
| Intervention |
Conventional Inferior alveolar nerve block plus long buccal nerve block |
Conventional Inferior alveolar nerve block plus long buccal nerve block with 2% lignocaine Hydrochloride and 1:100000 adrenaline bitartrate will be administered for duration of 1 minute each |
| Intervention |
Conventional Inferior alveolar nerve block plus premedication with Paracetamol |
Premedication with Paracetamol one hour before treatment will be given and Conventional Inferior alveolar nerve block with 2% lignocaine Hydrochloride and 1:100000 adrenaline bitartrate will be administered for duration of 1 minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The subjects should be actively experiencing pain and in good health, and none will be taking any medication that would alter pain perception.
|
|
| ExclusionCriteria |
| Details |
pregnant patients or patients with cardiovascular diseases, patients with history of allergy to any type of local anesthetic drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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 the randomized controlled trial comparing the patient’s pain intensity of conventional IANB to conventional IANB plus local infiltration, conventional IANB plus long buccal nerve block, conventional IANB plus premedication with paracetamol and conventional IANB plus cryotherapy with Endo Frost while performing endodontic treatment on mandibular molars. Null hypothesis is that there is no significant difference between patient’s pain intensity of conventional IANB to conventional IANB plus local infiltration, conventional IANB plus long buccal nerve block, conventional IANB plus premedication with paracetamol and conventional IANB plus cryotherapy with Endo Frost while performing endodontic treatment on mandibular molars. Total of 50 patients will be included in study having symptomatic irreversible pulpitis and 10 patients for each group will be selected. Pain will be recorded on Heft Parker Visual Analog Scale.
|