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CTRI Number  CTRI/2021/11/038274 [Registered on: 26/11/2021] Trial Registered Prospectively
Last Modified On: 25/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   BUFFERED LOCAL ANAESTHESIA VERSUS NON BUFFERED LOCAL ANAESTHESIA IN MINOR ORAL SURGERY 
Scientific Title of Study   Effect of Buffered local anaesthesia in Minor Oral Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SRUJANA TANGELLA 
Designation  POST GRADUATE  
Affiliation  Kaloji Narayana Rao University of Health Sciences 
Address  Department of Oral and Maxillofacial Surgery, Room no 2,MNR Dental College & Hospital MNR Nagar, Fasalwadi, Narsapur Road, Sangareddy

Hyderabad
TELANGANA
502294
India 
Phone  08978912802  
Fax    
Email  srujana1727@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  HARSHA GORRELA 
Designation  HOD and Professor 
Affiliation  Kaloji Narayana Rao University of Health Sciences 
Address  MNR Dental College & Hospital MNR Nagar, Fasalwadi, Narsapur Road, Sangareddy

Medak
TELANGANA
502294
India 
Phone  9848389869  
Fax    
Email  drgharshaomfs@gmail.com  
 
Details of Contact Person
Public Query  
Name  SRUJANA TANGELLA 
Designation  POST GRADUATE  
Affiliation  Kaloji Narayana Rao University of Health Sciences 
Address  Department of Oral and Maxillofacial Surgery, Room no. 2, MNR Dental College and Hospital, MNR nagar, Sangareddy

Medak
TELANGANA
502294
India 
Phone  8978912802  
Fax    
Email  srujana1727@gmail.com  
 
Source of Monetary or Material Support  
MNR Dental College and Hospital, Sangareddy 
 
Primary Sponsor  
Name  MNR Dental College and Hospital 
Address  MNR nagar, Fasalwadi, Sangareddy, Telangana 502294 
Type of Sponsor  Other [DENTAL COLLEGE AND HOSPITAL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
srujana tangella  MNR Dental college and hospital  Department of Oral and Maxillofacial Surgery, room no. 2
Medak
TELANGANA 		 8978912802

srujana1727@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MNR INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gross tooth decay 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% lignocaine hydrochloride with 1:80,000 adrenaline  2% lignocaine hydrochloride with 1:80,000 adrenaline inflitration given on the buccal and palatal side of the tooth to be extracted one time. Duration of infiltration 15 seconds approximately 
Comparator Agent  Inj. SODAC  2% lignocaine hydrochloride with 1:80,000 adrenaline buffered with 8.4% sodium bicarbonate given on the buccal and palatal side of the tooth to be extracted one time. Duration of infiltration 15 seconds approximately 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients with bilateral grossly decayed maxillary molars, indicated for extraction 
 
ExclusionCriteria 
Details  subjects taking any medication such as analgesics that may alter anaesthetic assessment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
pain measured using visual analog scale  1 min, 2 min, 3 min, 4 min, 5 min, 6 min 
 
Secondary Outcome  
Outcome  TimePoints 
onset of local anaesthesia measured from the time of infiltration to the time the patient perceived no pain in minutes  30 seconds, 1 min, 2 min, 3 min, 4 min, 5 min 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   29/11/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [srujana1727@gmail.com].

  6. For how long will this data be available start date provided 15-11-2022 and end date provided 15-11-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

 Local anaesthetics suffer several drawbacks such as vasopressor sting on injection, a relatively slower onset etc. Therefore, this study will be aimed at comparing the efficacy of buffered to non buffered local anaesthesia with respect to pain on infiltration, onset and duration of local anaesthesia.

This is a randomised controlled trial will be done on 100 patients who require bilateral extraction of grossly decayed maxillary molar teeth. The sample will be divided into study and control groups by a computer generated randomizer. In the study group, patients will be given buffered local anaesthesia (prepared by mixing 2% lignocaine with 1:80,000 adrenaline and 8.4% sodium bicarbonate) before extraction. In the control group, non buffered local anaesthesia (2% lignocaine with 1:80,000 adrenaline) will be given

 
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