| CTRI Number |
CTRI/2018/06/014559 [Registered on: 18/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical study to evaluate the effect of 2% lignocaine injection with alkalinized 2% lignocaine injection for tooth removal |
|
Scientific Title of Study
|
A prospective double blind randomised control trial on efficacy of buffered 2% lignocaine with 1: 80,000 epinephrine versus non buffered solution |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Bharatiram |
| Designation |
Senior Lecturer |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Room no 2
Vishnu Dental College
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492606016 |
| Fax |
|
| Email |
bharathiramomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kishore Moturi |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Room no 2
Vishnu Dental College
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9849094159 |
| Fax |
|
| Email |
moturik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kishore Moturi |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Room no 2
Vishnu Dental College
ANDHRA PRADESH
534202
India |
| Phone |
9849094159 |
| Fax |
|
| Email |
moturik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure facility: Vishnu Dental College, Bhimavaram
Materials:
1. Sodium Bicarbonate (SODAC) NEON LABORATORIES
2. Normal Saline, BAXTER INDIA PRIVATE LIMITED
3. LIGNOCAINE AND ADRENALINE INJECTION (LIGNOX 2% A)
(adrenaline 1: 80,000) , INDOCO REMEDIES LTD.
|
|
|
Primary Sponsor
|
| Name |
G Bharatiram |
| Address |
Department of Oral and Maxillofacial Surgery
Vishnu Dental College Bhimavaram
Andhra Pradesh
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kishore Moturi |
Professor and Head
Department of Oral and Maxillofacial Surgery
Vishnu Dental College Bhimavaram
Andhra Pradesh
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kishore Moturi |
Vishnu Dental College |
Department of Oral and Maxillofacial Surgery
Block III
Room no 2
Bhimavaram 534202
West Godavari
ANDHRA PRADESH
West Godavari
ANDHRA PRADESH |
9849094159
moturik@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 |
Injection pain and anesthetic latency in those requiring dental extractions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buffered LA solution |
2% Lignocaine with 1:80,000 epinephrine with 8.4% sodium bicarbonate at a 9:1 ratio |
| Comparator Agent |
Non Buffered Local Anesthesia |
2% Lignocaine with 1:80,000 epinephrine with 0.9% normal saline at a 9:1 ratio |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy participants those requiring bilateral dental extractions
2. Patients in the age group of 18- 50 years |
|
| ExclusionCriteria |
| Details |
1. Patients with debilitating systemic diseases
2. Patients with renal and cardiac problems
3. Pregnant women
4. Patients having abscess, cyst, space infections associated with teeth to be extracted.
5. Subjects who had analgesic or anti inflammatory drugs 24 hours before treatment
6. Patients allergic to the drugs under study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain on injection with 5 point Likert Scale |
3-120 seconds on injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anesthetic latency (time of onset)
|
5 minutes after the injection |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/12/2017 |
| Date of Study Completion (India) |
30/03/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to compare the
anesthetic latency and injection pain for Buffered Local Anesthesia versus Non
Buffered Local Anesthesia. In this double-blind, placebo-controlled, cross over
investigation, 25 patients those requiring bilateral dental extractions under
local anesthesia are selected. The sides of patients were randomized to
Buffered Local Anesthesia or Non Buffered Local Anesthesia group. Evaluation of
pain on injection (carried out with the use of a 5- point Likert scale) and anesthetic
latency (time of onset) are carried out.
|