| 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
|
|
|
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
|
|
|
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
|
|
|
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. |