FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088387 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Combining Local Anaesthetics with steroid: Applications in Lower Third Molar Surgeries  
Scientific Title of Study   Combining Local Anaesthetics with Triamcinolone Acetonide: Applications in lower Third Molar Surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avni Maheshwari 
Designation  PG student 
Affiliation  Jaipur Dental College 
Address  Department Of Oral And Maxillofacial Surgery

Jaipur
RAJASTHAN
302028
India 
Phone  08764185165  
Fax    
Email  avnipartani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avni Maheshwari 
Designation  PG student 
Affiliation  Jaipur dental College 
Address  Department Of Oral And Maxillofacial Surgery

Jaipur
RAJASTHAN
302028
India 
Phone  08764185165  
Fax    
Email  avnipartani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avni Maheshwari 
Designation  PG student 
Affiliation  Jaipur Dental College 
Address  Department Of Oral And Maxillofacial Surgery

Jaipur
RAJASTHAN
302028
India 
Phone  08764185165  
Fax    
Email  avnipartani@gmail.com  
 
Source of Monetary or Material Support  
Department Of Oral And Maxillofacial Surgery, Jaipur dental College Maharaj Vinayak Global University 302028- infrastructure, patient support 
 
Primary Sponsor  
Name  Dr Avni Maheshwari 
Address  Jaipur Dental College Maharaj Vinayak Global University 302028 
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 Avni Maheshwari  Gomtipur Referral Hospital  Room No 3 Rupani Dental Care
Ahmadabad
GUJARAT 		 8764185165

avnipartani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharaj Vinayak Global University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lignocaine 2% with 1:80,000 adrenaline  this will be used as nerve block in one group as inferior alveolar nerve block 
Intervention  Triamcinolone Acetonide 40mg with Lignocaine 2% with 1:80,000 adrenaline  this will be used as nerve block in one group as inferior alveolar nerve block 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Both male and female patients
Age group of 18 to 50 years
Patients with impacted mandibular third molar
Patients with NO systemic illness
Patients not allergic to bupivacaine
Patients willing to give the consent
Patients willing to come for a follow-up
 
 
ExclusionCriteria 
Details  Patients above the age of 50 years
Patients with erupted/non-impacted lower third molar
Patients with systemic illness/immunocompromised status
Patients not willing to give consent
Patients allergic to triamcinolone acetonide and bupivacaine
Noncompliance of patient in taking postoperative medication
Inability to appear for follow-up
Local pathology like cyst/tumor associated with third molar
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain Managment   1 day, 3rd day, 7 day 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative discomfort analysis  1 day, 3rd day, 7th day 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/06/2025 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
  • This study will be conducted in the out-patient clinic of Department of OMFS, Jaipur Dental College, Jaipur, Rajasthan
  • The study will be a Clinical Trial, wherein 25+25+25 patients will be undertaken in each group.
  • Written consent would be obtained from the patient after explaining the study and the motive behind it
  • 25 patients will receive lignocaine 2% as local anesthetic solution.
  • 25 patients will receive a combination of triamcinolone acetonide 40mg with lignocaine 2% as local anesthetic solution
  • 25 patients will receive a combination of triamcinolone acetonide 40mg with bupivacaine 0.5% as LA solution.
  • The study would be conducted in accordance with the Helsinki Declaration of 1975, revised in 2000
  • Postoperative instructions will be given to patients to bite on the cotton gauze firmly for 10-20 minutes, to avoid spitting for 24 hours, to continue prescribed medications regularly, to apply ice pack extra orally within 24 hours of surgery, to carry out warm saline rinsing after 24 hours of surgery and to refrain from smoking and vigorous oral rinsing.
  • Patients to be evaluated on the 2nd,3rd , 5th  and 7th  postoperative day
 
Close