| CTRI Number |
CTRI/2024/12/077839 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Buffered and Non-Buffered Lidocaine for Tooth Extractions |
|
Scientific Title of Study
|
COMPARISON OF BUFFERED AND NON-BUFFERED LIDOCAINE FOR THERAPEUTIC EXTRACTIONS: A SPLIT-MOUTH, DOUBLE-BLINDED, RANDOMIZED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer Pandey |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College |
| Address |
Department of Oral and Maxillofacial Surgery Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
917999597901 |
| Fax |
|
| Email |
sameerpandey14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Pandey |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College |
| Address |
Department of Oral and Maxillofacial Surgery Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
917999597901 |
| Fax |
|
| Email |
sameerpandey14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul Jain |
| Designation |
Post Graduate |
| Affiliation |
Subharti Dental College |
| Address |
Department of Oral and Maxillofacial Surgery Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
918360180965 |
| Fax |
|
| Email |
jain.vipulmj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Associate Professor
Department of Oral and Maxillofacial Surgery Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut. |
|
|
Primary Sponsor
|
| Name |
Dr Sameer Pandey |
| Address |
Associate Professor
Department of Oral and Maxillofacial Surgery Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut. |
| 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 Sameer Pandey |
Subharti Dental College and Hospital |
Department of Oral and Maxillofacial Surgery, Room no. 5
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
7999597901
sameerpandey14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical)Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local infiltration in patients requiring extractions for therapeutic purposes |
After screening the patients for inclusion criteria, randomization will be used to assign the type lignocaine (buffered or plain)which is to be infiltrated in right and left side of single mouth. The patients and operator will be kept blinded in this whole study. |
| Comparator Agent |
On one side of mouth buffered lidocaine (1ml 7.5% NaHCO3 + 9ml 2% Lidocaine) with 1:80000 adrenaline will be given and on the other side non-buffered lidocaine(1ml sterile water for injection + 9ml 2% Lidocaine) with 1:80000 adrenaline will be given. |
After giving local infiltration, both sides of single mouth will be evaluated for the parameters of study. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients who want therapeutic extractions for orthodontic purpose |
|
| ExclusionCriteria |
| Details |
Patients requiring extractions other than therapeutic purpose |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain on injection
2.Onset of action
|
1.Pain on injection is seen immediately at time of deposition of lignocaine.
2.Onset of action is seen in seconds immediately after injecting lignocaine.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quantity of local anesthetic required in ml
2. Subjective pain score at the time of extraction using VAS |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/12/2024 |
| Date of Study Completion (India) |
24/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
It is a split mouth double blinded randomized controlled trial, to compare the clinical effectiveness of buffered versus non-buffered lidocaine in
therapeutic extractions by assessing the onset of anesthesia, pain
perception during injection and amount of anesthetic solution injected. A total sample size of 34 patients (both male and female) will be enrolled in this study. Pain on injection will be evaluated at the time of injection subjectively by Visual Analog Scale, onset of anesthesia will be evaluated in seconds after injection subjectively and objectively by probing. |