| CTRI Number |
CTRI/2017/05/008544 [Registered on: 12/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dexamethasone on the efficacy of anesthesia in painful teeth |
|
Scientific Title of Study
|
A Prospective Randomized Double Blind Clinical Trial to Assess the Efficacy of Twin Mix and Lidocaine on Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis |
| Trial Acronym |
IANB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAMTA KAUSHIK |
| Designation |
Professor and Head |
| Affiliation |
Army College of Dental Sciences |
| Address |
Deparment of Conservative Dentistry and Endodontics
Room no 9
Army College of Dental Sciences
Jai Jawahar Nagar
CRPF-Chennapur road
Secunderabad
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
Secunderabad
Hyderabad
ANDHRA PRADESH
500087
India |
| Phone |
9391010325 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAMTA KAUSHIK |
| Designation |
Professor and Head |
| Affiliation |
Army College of Dental Sciences |
| Address |
Conservative Dentistry and Endodontics
Army College of Dental Sciences
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
Secunderaba
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
Secunderabad
Hyderabad
ANDHRA PRADESH
500087
India |
| Phone |
9391010325 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA KAUSHIK |
| Designation |
Professor and Head |
| Affiliation |
Army College of Dental Sciences |
| Address |
Conservative Dentistry and Endodontics
Army College of Dental Sciences
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
Secunderabad
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
Secunderabad
Hyderabad
ANDHRA PRADESH
500087
India |
| Phone |
9391010325 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army College of Dental Sciences;
Jai Jawahar Nagar
CRPF-Chennapur Road
Balaji Nagar
SecunderabadSecunderabad |
|
|
Primary Sponsor
|
| Name |
Mamta Kaushik |
| Address |
Army College of Dental Sciences
Jai Jawahar Nagar
CRPF-Chennapur Road
Secunderabad |
| Type of Sponsor |
Other [Personally funded but conducted in the Dental 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 |
| Mamta Kaushik |
Army College of Dental Sciences |
Jai jawahar Nagar
CRPF-Chennapur Road
Secunderabad
Hyderabad
ANDHRA PRADESH |
9391010325
mamkaushik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient clinically diagnosed with irreversible pulpitis
Age: 18-50 years
Currently feeling pain:
Good health
Not taking any medication that would alter the perception of pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone with Lidocaine |
4mg Dexamethasone in 1:200000 Epinephrine 2% Lidocaine |
| Comparator Agent |
Lidocaine |
1:200000 Epinephrine and 2% Lidocaine; compared to ;
4mg Dexamethasone mixed with 1:200000 Epinephrine and 2% Lidocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18-50 years
2. Currently feeling pain:
3. Good health
4. Not taking any medication that would alter the perception of pain determined by verbal questioning and written questionnaire.
5. Patient has to be clinically diagnosed with irreversible pulpitis on the basis of
1. Moderate to severe spontaneous pain
2. Prolonged response to cold testing and
3. Positive response to the electric pulp test |
|
| ExclusionCriteria |
| Details |
Existence of acute infection and/or swelling
Systemic disorders
History of complications associated with LA
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Twin Mix may prove to be an effective anesthetic in cases of Irreversible Pulpitis |
The result will be evaluated in 25 minutes after injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Twin Mix may prove to be more effective as compared to Lidocaine in cases of Irreversible Pulpitis |
Routine Clinical Application |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/01/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Anesth Prog. 2020 Dec 1;67(4):207-213. doi: 10.2344/anpr-67-03-11. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Achieving successful pulpal anaesthesia in healthy mandibular teeth is a challenge for the practitioner, with a success rate of 51-65% . There have been multiple suggestions to control this pain : 1. Supplementary anaesthesia – Intraligamentary Intraosseous Intrapulpal 2. buccal infiltrations of articaine, ketarol, dexamethasone 3. Premedication with analgesics and steroids ( Ibuprofen, Ketarol, Dexamethazone ) Use of steroid as oral, parental and submucosal routes has been extensively studied in third molar impaction surgeries. One method of delivery suggested is mixing the steroid in the LA solution – TWIN MIX This mixture has been extensively studied and found to be very effective . The efficacy in teeth with irreversible pulpitis has not been studied The aim of this study is to assess the anaesthetic efficacy of twin mix for achieving successful pulpal anaesthesia when used in IANB, and in cases of irreversible pulpitis. |