FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044351 [Registered on: 26/07/2022] Trial Registered Prospectively
Last Modified On: 26/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the effect of premedication on success of Local anesthesia in pulpal inflammation 
Scientific Title of Study   To evaluate the efficacy of premedication with non steriodal anti-inflammatory drugs, corticosteriods and placebo on success of inferior alveolar nerve block in achieving pulpal anaesthesia in symptomatic irreversible pulpitis-A randomized control double blinded study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geethanjali R 
Designation  Post graduation student 
Affiliation  Karpaga vinayaga institute of dental sciences 
Address  Karpaga vinayaga institute of dental sciences Department of conservative dentistry and endodontics medical girls hostel Room no.F18 madhurathakam chengalpettu

Kancheepuram
TAMIL NADU
603308
India 
Phone  7708411919  
Fax    
Email  geety97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Madhuram K 
Designation  Head of the department 
Affiliation  Karpaga vinayaga institute of dental sciences 
Address  Karpaga vinayaga institute of dental sciences Department of conservative dentistry and endodontics madhurathakam chengalpettu

Kancheepuram
TAMIL NADU
603308
India 
Phone  9962677450  
Fax    
Email  madhu_endo@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Geethanjali R 
Designation  Post graduation student 
Affiliation  Karpaga vinayaga institute of dental sciences 
Address  Karpaga vinayaga institute of dental sciences Department of conservative dentistry and endodontics medical girls hostel Room no.F18 madhurathakam chengalpettu

Kancheepuram
TAMIL NADU
603308
India 
Phone  7708411919  
Fax    
Email  geety97@gmail.com  
 
Source of Monetary or Material Support  
Karpaga vinayaga institute of dental sciences 
 
Primary Sponsor  
Name  Geethanjali R 
Address  Karpaga vinayaga institute of dental sciences medical ladies hostel chengalpettu  
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 
Geethanjali R  karpaga vinayaga institute of dental sciences  karpaga vinayaga institute of dental sciences Department of conservative dentistry and endodontics Room no.4 madhuranthakam kancheepuram
Kancheepuram
TAMIL NADU 		 7708411919

geety97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee karpaga vinayaga institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R50-R69||General symptoms and signs, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  oral piroxicam Ketrolac Dt oral prednisolone oral dexamethasone   20 mg oral piroxicam 10mg oral Ketrolac Dt 5 mg oral prednisolone 1 mg oral dexamethasone. The route of administration is oral and is given 1 hour prior to the treatment 
Comparator Agent  Placebo  zincovit. The route of administration is oral and is given 1 hour prior to the treatment 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy individuals of age 19 to 45
2.Subjects participating in the study had first or second mandibular molar teeth with symptomatic irreversible pulpitis.
3.Patients with no systemic disease 
 
ExclusionCriteria 
Details  1.Patients who are allergic or sensitive to local anesthesia and drugs used in this study
2.Pregnant or lactating women
3.Patients who had taken any analgesic medication in the preceding 12 hours before the treatment.
4.Patients with history of peptic ulcer
6.Patients not willing to provide informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the success rate of Inferior alveolar nerve block with use of premedications.   1 hour
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the success rate of Inferior alveolar nerve block with use of premedications.   at baseline

 
 
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 4 
Date of First Enrollment (India)   01/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2022 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a double blinded,randomized control study comparing the effect of premedication with two non steriodal anti inflammatory drugs; Piroxicam 20mg and Ketorolac 10mg  and two corticosteroids -  Dexamethasone 1mg and Prednisolone 5mg with a placebo  Zincovit on success of inferior alveolar nerve block in symptomatic irreversible pulpitis. 
Close