| CTRI Number |
CTRI/2021/07/034900 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the efficacy of intravenous and submucosal routes of Dexamethasone administration in
reducing post-operative complications after lower third molar surgery. |
|
Scientific Title of Study
|
A comparative study on the efficacy of intravenous versus submucosal routes of Dexamethasone administration in reducing post-operative sequelae after lower third molar surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrThajunnisa M k |
| Designation |
Post graduate student |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of oral and maxillofacial surgery.Room number 2.Coorg Institute of dental sciences.K K campus.Maggula.Virajpet.Kodagu
K k campus.Maggula.Virajpet.Kodagu.
Kodagu
KARNATAKA
571218
India |
| Phone |
9972961433 |
| Fax |
|
| Email |
drtajabooty12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrasanna Kumar P |
| Designation |
Professor and head of the department |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of oral and maxillofacial surgery. Room number 2.Coorg Institute of dental sciences.K K campus.Maggula.Virajpet.Kodagu.
K K campus.Maggula.Virajpet.kodagu.Karnataka.
Kodagu
KARNATAKA
571218
India |
| Phone |
9886122780 |
| Fax |
|
| Email |
prasannamaxface@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrasanna Kumar P |
| Designation |
Professor and head of the department |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of oral and maxillofacial surgery. Room number 2.Coorg Institute of dental sciences.K K campus.Maggula.Virajpet.Kodagu.
K K campus.Maggula.Virajpet.kodagu.Karnataka.
Kodagu
KARNATAKA
571218
India |
| Phone |
9886122780 |
| Fax |
|
| Email |
prasannamaxface@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
DrThajunnisa M K |
| Address |
Department of oral and maxillofacial surgery. Room number 2.Coorg institute of dental sciences.K K campus.Maggula.Virajpet.Kodagu.Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrThajunnisa M K |
Coorg institute of dental sciences |
Department of oral and maxillofacial surgery.Room number 2.K K campus.Maggula. Virajpet.
Kodagu
KARNATAKA |
9972961433
drtajabooty12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
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 |
Dexamethasone 8mg. |
Intravenous and submucosal routes of administration of Dexamethasone.
Single dose post-operatively. |
| Intervention |
Surgical removal of impacted third molar. |
Comparison of efficacy of intravenous and submucosal routes of administration of Dexamethasone after surgical removal of impacted third molars. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age18years or higher with an impacted third molar irrespective of sex are included in this study.
No history of pericoronitis and previous infection in the impacted teeth site.
Patients with an adequate mouth opening and good oral hygiene. |
|
| ExclusionCriteria |
| Details |
Patients with existing active infection.
Patients with systemic disorders.
Patients on long term steroids.
Pregnant and lactating women.
Patients under radiotherapy or chemotherapy.
Allergy to drug used in the study. |
|
|
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 |
| Reduction in pain,swelling and trismus. |
On 1st 3rd and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing comfort of patient. |
1st 3rd and 7th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/07/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare intravenous and submucosal routes of administration of Dexamethasone immediate postoperatively after lower third molar surgery. The objective of the study is to identify the simplest and the most effective route to minimize post operative discomfort. To ensure early return to normalcy. To measure patients perceptions of changes in their quality of life after mandibular third molar extraction. |