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CTRI Number  CTRI/2021/02/031509 [Registered on: 23/02/2021] Trial Registered Prospectively
Last Modified On: 24/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Is tramadol an alternative to lignocaine for removal of tooth?  
Scientific Title of Study   Effectiveness of tramadol compared to lignocaine as a local anesthesia in extraction of firm tooth- a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manu Goel 
Designation  Associate Professor 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur 
Address  Department of Oral and Maxillofacial Surgery
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital
Nagpur
MAHARASHTRA
441 110
India 
Phone  09011794068  
Fax    
Email  mrimanster@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manu Goel 
Designation  Associate Professor 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur 
Address  Department of Oral and Maxillofacial Surgery
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital
Nagpur
MAHARASHTRA
441 110
India 
Phone  09011794068  
Fax    
Email  mrimanster@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manu Goel 
Designation  Associate Professor 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur 
Address  Department of Oral and Maxillofacial Surgery
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital
Nagpur
MAHARASHTRA
441 110
India 
Phone  09011794068  
Fax    
Email  mrimanster@gmail.com  
 
Source of Monetary or Material Support  
SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL, NAGPUR 
 
Primary Sponsor  
Name  Manu Goel 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur 
Type of Sponsor  Other [Self] 
 
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 
Dr Manu Goel  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur  department no.101, Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA 		 9011794068

mrimanster@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDKS dental college institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.8 ml of 2% Lignocaine  1.8 ml of 2% Lignocaine without vasocontrictor is infiltrated supreaperiosteally and signs and symptoms of anesthesia are checked. Excessive amount of same drug is injected in necessary cases where one injection was not sufficient for achieving anesthesia. Dration of therapy was till completion of tooth extraction process. 
Intervention  1.8 ml of 5% Tramadol  1.8 ml of 5% Tramadol without vasoconstrictor is infiltrated supreaperiosteally and signs and symptoms of anesthesia are checked. Excessive amount of same drug is injected in necessary cases where one injection was not sufficient for achieving anesthesia. Dration of therapy was till completion of tooth extraction process. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Firm but Grossly decayed maxillary first molars.
2.Firm Root pieces with maxillary first molars.
 
 
ExclusionCriteria 
Details  1)Medically compromised individuals.
2)pregnant or lactating females.
3)those who were allergic to the drugs used in the trial.
4)Patients not willing to consent for the study. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intra operative pain  till the completion of extraction procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of solution used as anesthetic agebt  till the completion of extraction procedure 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   26/02/2021 
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="0"
Months="0"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomized double blind trial comparing the efficiency of Tramadol versus Lignocaine as local anesthetic for dental extraction of firm maxillary first molars that will be conducted in Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Nagpur. The primary outcome measure will be anesthetic efficiency of tramadol over lignocaine  in extraction of maxillary molars. The secondary outcome will be the amount of anesthetic agent used for completion of extraction. 
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