| CTRI Number |
CTRI/2022/06/043230 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of effects of methylprednisolone injection in masseter muscle versus deltoid muscle after wisdom tooth removal |
|
Scientific Title of Study
|
Efficacy of Methylprednisolone Administration into Masseter Muscle
versus Deltoid Muscle on Postoperative Sequelae in Minor Oral Surgery: A
Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravesh Mehra |
| Designation |
Director Professor and Head of Department, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Oral and Maxillofacial Surgery,
Lady Hardinge Medical College,
New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
9968091458 |
| Fax |
|
| Email |
csrmehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjeet Gambhir |
| Designation |
Associate Professor, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Oral and Maxillofacial Surgery,
Lady Hardinge Medical College,
New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
8427543060 |
| Fax |
|
| Email |
amarjeetgambhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Shinde |
| Designation |
Postgraduate Student, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Oral and Maxillofacial Surgery,
Lady Hardinge Medical College,
New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
7498087499 |
| Fax |
|
| Email |
shindemadhuri86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College and Associated Hospitals,
Shaheed Bhagat Singh Marg,
New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
The Director |
| Address |
Lady Hardinge Medical College and Associated Hospitals,
Shaheed Bhagat Singh Marg,
New Delhi-110001 |
| Type of Sponsor |
Government medical college |
|
|
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 Pravesh Mehra |
Lady Hardinge Medical College |
Dental Surgical Clinics, Room No. 1 to 4,
Department of Dental and Oral Surgery,
Lady Hardinge Medical College and Associated Hospitals,
Shaheed Bhagat Singh Marg,
New Delhi-110001
New Delhi
DELHI |
7982141142
csrmehra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICAL COLLEGE & ASSOCIATED HOSPITALS, SHAHID BHAGAT SINGH MARG, NEW DELHI-110001, INDIA |
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 |
Inj. Methylprednisolone 40 mg Intramasseter administration |
preoperatively after achieving adequate anesthesia Inj. Methylprednisolone 40mg Intramasseter administration. |
| Comparator Agent |
Inj. Methylprednisolone 40mg Intradeltoid administration |
preoperatively after achieving adequate anesthesia Inj. Methylprednisolone 40mg Intradeltoid administration. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Partially or completely bony/soft tissue impacted mandibular third molars.
2. Age group 20-40 years.
|
|
| ExclusionCriteria |
| Details |
1. Acute infection of odontogenic and non-odontogenic causes.
2. Pregnant and lactating females.
3. Patients with known systemic disorder such as diabetes mellitus, hypertension, thyroid disorder, immunocompromised state etc.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of mean pain intensity scores of group 1 and group 2 as assessed by visual analogue scale.
2. Comparison of facial edema as assessed by mean distance between : Tragus and lip commissure, tragus and soft tissue pogonion, gonion and external canthus of eye of group 1 and group 2.
3. Comparison of mean values of maximum interincisal opening of group 1 and group 2. |
Preoperatively on the day zero (day of surgery) and on the first, third, and seventh post-operative days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of mean scores of wound healing of group 1 and group 2 as assessed by healing index by Landry et al.
2. Comparison of total number of postoperative analgesics taken for group 1 and group 2.
|
On the first, third, and seventh post-operative days. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2022 |
| Date of Study Completion (India) |
10/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the randomized controlled trial is to compare efficacy of methylprednisolone administration in masseter muscle versus deltoid muscle on postoperative sequalae in minor oral surgery. Patients with partially or completely bony/soft tissue impacted mandibular third molars with age group of 20-40 years will be included in the study. The primary and secondary parameters for comparison includes pain, facial edma, maximum interincisal opening, wound healing assessment and total number of postoperative analgesics taken by patient. Clinical assessment of the patients will be done on the day of surgery and first, third and seventh day postoperatively. |