| CTRI Number |
CTRI/2025/08/093149 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study compares how well two medicines that is tramadol (a painkiller) and dexamethasone (which helps reduce swelling), works when injected under the gum, to see which one better helps with pain, swelling, and other problems after the surgical removal of a lower wisdom tooth. |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Submucosal Injection Of Tramadol Vs Dexamethasone In Reducing Post Operative Sequelae In Impacted Mandibular Third Molar Extraction : A Prospective, Randomised, Placebo Controlled, A Triple Blind Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHATOI SOCIA |
| Designation |
PG student |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL COLLEGE |
| Address |
1ST FLOOR MAULANA AZAD DENTAL COLLEGE, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,
Central
DELHI
110002
India |
| Phone |
8787739973 |
| Fax |
|
| Email |
chatoisocia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PANKAJ SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL COLLEGE |
| Address |
1ST FLOOR MAULANA AZAD DENTAL COLLEGE, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,
Central
DELHI
110002
India |
| Phone |
9654958541 |
| Fax |
|
| Email |
Spankajomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHATOI SOCIA |
| Designation |
PG student |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL COLLEGE |
| Address |
1ST FLOOR MAULANA AZAD DENTAL COLLEGE, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,
DELHI
110002
India |
| Phone |
8787739973 |
| Fax |
|
| Email |
chatoisocia@gmail.com |
|
|
Source of Monetary or Material Support
|
| maulana azad institute of dental sciences, delhi |
|
|
Primary Sponsor
|
| Name |
chatoi socia |
| Address |
1st floor maulana azad institute of dental sciences, delhi |
| Type of Sponsor |
Research institution 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 CHATOI SOCIA |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
1st floor, Maulana Azad Institute of Dental Sciences, MAMC, Bahadur shah Zafar Marg, central Delhi
Central
DELHI |
8787739973
chatoisocia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
DEXAMETHASONE |
SUBMUCOSAL INJECTION OF 4mg/ml (1ml) DEXAMETHASONE IN MANDIBULAR THIRD MOLAR DISIMPACTION CASES |
| Comparator Agent |
NORMAL SALINE |
SUBMUCOSAL INJECTION OF 1ml of 0.9% NORMAL SALINE IN THE MANDIBULAR THIRD MOLAR DISIMPACTION CASES |
| Intervention |
TRAMADOL |
SUBMUCOSAL INJECTION OF 50mg/ml (1ml) TRAMADOL IN MANDIBULAR THIRD MOLAR DISIMPACTION CASES o |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Above 18 years of age, any sex.
2 Impacted mandibular third molar (which require transalveolar extraction) with Pederson difficulty index- moderately difficult (5-7)
3 American Society of Anesthesiologists (physical status classification)- class 1
|
|
| ExclusionCriteria |
| Details |
• Age below 18 years
• Patient with history of any systemic illness
• Patients with pericoronitis or local acute infection at the time of surgery.
• Pregnancy or lactating women.
• Drug allergy to tramadol and dexamethasone.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Reduction in swelling.
2) Improvement in mouth opening.
3) Reduction in pain.
|
postoperative 1st, 3rd and 7th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare rescue analgesia needed by the patient (duration & frequency) after submucosal injection of tramadol & dexamethasone postoperatively on 1st, 3rd & 7th day.
2. Side effects of drugs :
Nausea, vomiting, burning & dizziness etc
|
1st 3rd & 7th postoperative day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
27/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Background:Surgical removal of impacted mandibular third molars is frequently associated with postoperative sequelae such as pain, swelling, and trismus, which can significantly affect patient comfort and quality of life. Various pharmacological agents have been evaluated to minimize these outcomes. This study aims to compare the efficacy of submucosal injection of tramadol versus dexamethasone in controlling postoperative discomfort following third molar surgery. Materials and Methods:
A prospective, randomized, placebo-controlled, triple-blind clinical trial was conducted on 90 systemically healthy patients requiring mandibular third molar extraction. Patients were randomly allocated into three groups (n=30 each): Group A received 1 ml of tramadol (50 mg/ml), Group B received 1 ml of dexamethasone (4mg/ml), and Group C received 1 ml of normal saline (placebo) via submucosal injection immediately post-extraction. Standardized surgical protocol and postoperative care were maintained. Pain (measured using a Visual Analog Scale), facial swelling (measured using two-line facial measurement), and trismus (interincisal distance) were assessed on postoperative days 1, 3, and 7. |