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CTRI Number  CTRI/2025/12/099900 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of intravenous and submucosal Dexamethasone in transalveolar extraction of mandibular third molar 
Scientific Title of Study   Comparison of efficacy of intravenous and submucosal Dexamethasone in transalveolar extraction of mandibular third molar 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ratna More 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital 
Address  First Floor ,Department of oral and maxillofacial surgery,Government Dental College and Hospital ,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  09834143457  
Fax    
Email  moreratna305@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishit K. Shah 
Designation  tutor 
Affiliation  Government Dental College and Hospital 
Address  First Floor ,Department of oral and maxillofacial surgery,Government Dental College and Hospital ,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  09834143457  
Fax    
Email  drnishitomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ratna More 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital 
Address  First Floor ,Department of oral and maxillofacial surgery,Government Dental College and Hospital ,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  09834143457  
Fax    
Email  moreratna305@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Department of Oral and Maxillary Surgery ,Government Dental College and Hospital ,Jamnagar  
Address  First Floor, Room No-4,Department of Oral and Maxillofacial Surgery,Government Dental College and Hospital ,Jamnagar,361008 
Type of Sponsor  Other [Government Dental College and Hospital] 
 
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 Ratna More  Government Dental College and Hospital ,Jamnagar   Department of Oral and Maxillofacial Surgery ,Room no -4 ,Government Dental College and Hospital ,Jamnagar
Jamnagar
GUJARAT 
09834143457

moreratna305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe M.P .Shah Govt.Medical College and Guru Gobindsingh Hospital ,Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Dexamethasone   Comparative Evaluation of Intravenous and Submucosal Dexamethasone after Transalveolar Extraction Of Mandibular First Molar in order to evaluate post operative Pain ,Trismus and Wound healing. 
Comparator Agent  Submucosal Dexamethasone  Comparative Evaluation of Intravenous and Submucosal Dexamethasone after Transalveolar Extraction Of Mandibular First Molar in order to evaluate post operative Pain ,Trismus and Wound healing. 
 
Inclusion Criteria  
Age From  21.00 Day(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Partially or fully impacted mandibular third molar that requires surgical extraction.
2. Root formation should be complete.
3. Age 21-50 years.
4. Only ASA Class I of physical status classification 
 
ExclusionCriteria 
Details  1.Patient with immunocomprosised disease.
2.Periodonatally compromised posterior teeth.
3.Pregnancy and lactation.
4.ASA Class II of systemic classification and above.
5.Age less than 21 or more than 51 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of intravenous and submucosal dexamethasone in reducing postoperative swelling.
To evaluate the effectiveness of intravenous and submucosal dexamethasone in reducing postoperative trismus
To determine the overall patient satisfaction and comfort with each route.
To analyse any potential side effects or complications associated with each route.
 
Day 1,Day 3 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1Infection
2.Wound healing 
Day 1,Day 3,Day 7 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   10/01/2026 
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="1"
Months="6"
Days="20" 
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  

The  removal  of lower third molars is the most common surgical procedure done by oral and maxillo facial surgeons. It is often associated with swelling, pain and trismus as a result of the postoperative inflammatory response, and these can have a serious impact on the patient’s quality of life, as well as having financial consequences.When body tissues are injured the normal physiologic response is inflammation and pain to varying degree. Inflammation occurs after every surgical intervention and should be expected. The most important component of inflammation is vasodilation, which allows cells and mediators entry to the affected area; these are responsible for neutralizing and removing the antigens and the remains of damaged tissue.Corticosteroids  are often used to minimize the post-operative inflammation following surgical removal of mandibular third molar . Mechanism of action of corticosteroid includes inhibition of the enzyme phospholipase A2 , which inhibits the conversion of  phospholipids into arachidonic acid in the cells of the inflamed focus. This will decrease prostaglandin and leukotriene synthesis, therefore reducing the accumulation of neutrophils and thereby reducing inflammation.  Dexamethasone , with its long half-life, potency, and almost pure glucocorticoid activity makes it a safe and effective anti-infammatory drug . Dexamethasone  is usually administered via various routes like Intravenous, Intramuscular and Oral.

 
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