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CTRI Number  CTRI/2025/07/091794 [Registered on: 27/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare different injections to reduce swelling and pain during wisdom tooth removal 
Scientific Title of Study   Efficacy of submucosal Injection Aprotonin, Hyaluronidase and Dexamethasone during third molar surgery : A randomized controlled trial  
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 Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat- 360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat- 360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat- 360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rajkot 
Address  Room 115, All India Institute of Medical Sciences, Rajkot, Gujarat-360006 
Type of Sponsor  Research institution 
 
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 Shreeya Sharma  All India Institute of Medical Sciences  Room 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat- 360006
Rajkot
GUJARAT 		 8830388570

shreeyasharma231@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Rajkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aprotinin  Injection Aprotinin 2ml administered submucosally just before the incision single dose.Total duration is single administration on the day of surgery only 
Comparator Agent  Aprotinin, Hyaluronidase, Dexamethasone  Each intervention arm will serve as a comparator to the others in the multi-arm randomized trial  
Intervention  Dexamethasone  Injection Dexamethasone 2ml administered submucosally just before the incision single dose only during third molar surgery Total duration is single dose administration on the day of surgery only  
Intervention  Hyaluronidase   Injection Hyaluronidase 2ml administered submucosally just before the incision single dose only during third molar surgery Total duration is single dose administration on the day of surgery only  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy ambulatory patients reporting to the Department of Dentistry, AIIMS Rajkot requiring removal of single impacted lower third molars which necessitates mucoperiosteal flap elevation, buccal bone guttering with or without sectioning of tooth, Age between 18-50 years, slight and moderate difficult impaction based on radiographs. 
 
ExclusionCriteria 
Details  Patients with systemic diseases, pregnancy and breast-feeding or any other medicinal therapy that could interfere with healing process, use of any antibiotic or any anti-inflammatory drug within 1 week period, patient with preoperative swelling, reduced mouth opening, any abusive habits like tobacco chewing, alcohol consumption and smoking.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Postoperative facial swelling measured in millimeters using linear facial measurements.  Baseline(preoperatively),72 hrs, 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in interincisal mouth opening (in mm)  Baseline(preoperatively),72 hrs, 7 days 
Reduction in pain measured using Visual Analog Scale (VAS)  Baseline(preoperatively),72 hrs, 7 days 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   31/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Patients diagnosed with impacted mandibular third molar and radiographically graded as slight and moderate difficulty in removal according to Pederson index will be included. Demographic data with detailed history will be obtained about personal, habit and medical history followed by clinical examination and parameters will be evaluated such as swelling evaluation by sum of linear measurements, mouth opening by maximal interincisal distance using vernier callipers, pain will be assessed subjectively using visual analogue scale (VAS 0-10 cm) preoperatively, at 72 hrs and after 7 days.

 
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