| CTRI Number |
CTRI/2025/07/091400 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of dexamethasone in lower third molar removal. |
|
Scientific Title of Study
|
Assessment of effectiveness of pre-operative single dose intramuscular dexamethasone on post-operative outcomes following surgical removal of impacted lower 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 |
Sai Aditiya Narayanan R |
| Designation |
Postgraduate |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
No 2 Department of Oral and Maxillofacial Surgery Ragas Dental College and Hospital 2/102 East Coast Road Uthandi Chennai 600119
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9080967435 |
| Fax |
|
| Email |
saiaditiya1709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Vikraman |
| Designation |
HOD and Guide |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
No 2 Department of Oral and Maxillofacial Surgery Ragas Dental College and Hospital 2/102 East Coast Road Uthandi Chennai
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Vikraman |
| Designation |
HOD and Guide |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
No 2 Department of Oral and Maxillofacial Surgery Ragas Dental College and Hospital 2/102 East Coast Road Uthandi Chennai
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| No 2 Department of Oral and Maxillofacia Surgery Ragas Dental College and Hospital 2/102 East Coast Road Uthandi Chennai Tamil Nadu India 600119 |
|
|
Primary Sponsor
|
| Name |
Sai Aditiya Narayanan R |
| Address |
2/102 East Coast Road Uthandi Chennai 600119 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sai Aditiya Narayanan R |
Ragas Dental College and Hospital |
No 2, Department of Oral and Maxillofacial Surgery, 2/102, East Coast Road, Uthandi, Chennai 600119
Kancheepuram
TAMIL NADU |
9080967435
saiaditiya1709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Ragas Dental College and Hospital |
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 |
| Comparator Agent |
Placebo |
Placebo was given intramuscularly one hour before the procedure |
| Intervention |
Pre operative Intramuscular Dexamethasone |
Preoperatively administering dexamethasone intramuscularly to assess its effectiveness in postoperative outcome after surgical extraction of lower impacted third molar at posteoperative days 2 and 7 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
All patients who desire surgical extraction of bilaterally impacted lower third molar.
Age group between 18 - 35 years.
Both sexes would be included.
Patient with no presenting acute systemic illness such as fever, common cold etc.
Patient who are willing to participate in the study.
Be available for follow up examinations.
Patients with higher difficulty index of impacted teeth. greater than 5 in Pederson difficulty Index |
|
| ExclusionCriteria |
| Details |
History of systemic diseases that would contraindicate surgical treatment.
Compromised health conditions.
Patient with active infection like periapical access, pericoronitis etc.
Known allergy or contraindication to any of the medications to be used in the study.
Lack of willingness to participate in the study or lacking compliance to post-surgical instructions.
Patients with high risk of infection including smokers, malnutrition, immunosuppressive drugs.
Patients currently under steroids or having taken systemic steroids in the last 3 months.
Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, swelling and restriction in mouth opening and limitation in daily activities. |
Intraoperatively, Postoperative day 2 and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
19/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
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 is to be conducted on 10 patients with bilateral impacted lower third molar. An IOPA and Orthophantamogram will be taken for evaluation preoperatively. Informed consent will be obtained from all patients. The impacted molars are to be removed at a one-month interval, with surgical difficulty assessed using the Pederson difficulty index and WHARFE assessment. All procedures will be performed by the same operator under local anesthesia. One side was assigned to Group A, receiving an 8mg intramuscular injection of dexamethasone one hour pre-operatively, while the contralateral side Group B served as a control, receiving no pre-operative medication. Standardized surgical and analgesic protocols were followed. Postoperative assessment for swelling, restriction in mouth opening, pain and limitation in daily activities was recorded on 2nd and 7th postoperative days. |