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CTRI Number  CTRI/2020/02/023261 [Registered on: 11/02/2020] Trial Registered Prospectively
Last Modified On: 29/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   to achieve maximum anaesthetic success using ketorolac and pregabalin premedication with 1.7mL of articaine using Inferioor alveolar block with infiltration in symptomatic teeth 
Scientific Title of Study   Comparative Evaluation of Anaesthetic Success after Ketorolac and Pregabalin Oral Premedication for Inferior Alveolar Nerve Block with Buccal Infiltration in Symptomatic Mandibular Molars with Irreversible Pulpitis-- A Prospective, Randomized, Controlled, Double-Blind Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suruchi Agrawal 
Designation  Post Graduate Student 
Affiliation  SGT Dental College 
Address  Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,SGT University
Chandu-Budhera, Gurgaon-Badli road, Gurugram
Gurgaon
HARYANA
122505
India 
Phone  8955997107  
Fax    
Email  suru.34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mandeep S Grewal 
Designation  Head of Department 
Affiliation  SGT Dental College 
Address  Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University
Chandu-Budhera, Gurgaon-Badli road, Gurugram
Gurgaon
HARYANA
122505
India 
Phone  9810805880  
Fax    
Email  drmandeepsgrewal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Suruchi Agrawal 
Designation  Post Graduate Student 
Affiliation  SGT Dental College 
Address  Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University
Chandu-Budhera, Gurgaon-Badli road, Gurugram
Gurgaon
HARYANA
122505
India 
Phone  8955997107  
Fax    
Email  suru.34@gmail.com  
 
Source of Monetary or Material Support  
self sponsored Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT Dental College, SGT University  
 
Primary Sponsor  
Name  dr suruchi agrawal 
Address  sgt dental college, dept of conservative dentistry and endodontics, faculty of dental sciences,chandu-budhera, gurgaon-badli road, gurugram 
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 Suruchi Agrawal  SGT Dental College  Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Chandu-Budhera, Gurgaon-Badli road, Gurugram
Gurgaon
HARYANA 
8955997107

suru.34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Poonam Salwan, Mr Dinesh, Mr Azad Singh, Dr Anil Gupta, Dr Mandeep S Grewal, Mrs Achinder Chauhan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  irreversible pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  articaine is used  The dentist administering the local anesthetic agent.The access opening and instrumentation will be assigned to different dentist. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Symptomatic irreversible pulpitis
2 Patients with active pain in a mandibular first or/and second molar,
3 Patients in good health, with no previous history of allergy to any kind of local anesthesia, sulphites or other drugs that would alter pain perception.
4 Prolonged response to cold testing with Endo-frost (Roeko Langenace, Germany)
5 Absence of any periapical radiolucency on periapical radiographs
6 A vital coronal pulp on access opening.
 
 
ExclusionCriteria 
Details  1 Subjects younger than 18 years and older than 60
2 History of significant medical problems
3 Taken central nervous system depressants or any analgesic medication within 8 hours
4 Pregnancy
5 Allergy to articaine, ketorolac, pregabalin
6 Unable to give informed consent.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
compare the effect of oral premedication with ketorolac and pregabalin on anesthetic efficacy of inferior alveolar nerve block and buccal infiltration in symptomatic patients with irreversible pulpitis  pain assessment done at 15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/02/2020 
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="3"
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)?  

Brief Summary  

This is a prospective, randomized, controlled, double blind study will be to achieve maximum anaesthetic success using ketorolac and pregabalin premedication with 1.7mL of articaine IANB with BI in teeth with symptomatic IP. Sample size of this trial is 150 which is divided into three groups of 50 each. All patients will be asked to rate the pain on the HP VAS to analyse the level of pain during access opening and after instrumentation. 

 
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