| CTRI Number |
CTRI/2021/02/030987 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of dexamethasone injection in reducing post operative discomfort when given submucosally and intravenous |
|
Scientific Title of Study
|
Submucosal versus intravenous dexamethasone for the reduction of postoperative sequelae following oral minor surgical procedures:Randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNEHA SUSAN ZACHARIAH |
| Designation |
PG STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH
GOLDEN HILLS
Venkode po,Vattappara,Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9995352091 |
| Fax |
|
| Email |
snehasusuzach@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MATHEW THARAKAN |
| Designation |
PROFESSOR |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH
GOLDEN HILLS
Venkode po,Vattappara,Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8086429279 |
| Fax |
|
| Email |
drcamt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SNEHA SUSAN ZACHARIAH |
| Designation |
PG STUDENT |
| Affiliation |
PMS college of dental science and research |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH
GOLDEN HILLS
Venkode po,Vattappara,Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9995352091 |
| Fax |
|
| Email |
snehasusuzach@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SNEHA SUSAN ZACHARIAH
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH VATTAPPARA ,TRIVANDRUM,KERALA-695028 |
|
|
Primary Sponsor
|
| Name |
DR SNEHA SUSAN ZACHARIAH |
| Address |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,GOLDEN HILLS,VENKODE PO
VATTAPPARA,TRIVANDRUM-695028 |
| 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 |
| DR SNEHA SUSAN ZACHARIAH |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,GOLDEN HILLS,VENKODE PO,VATTAPPARA,TRIVANDRUM-695028
Thiruvananthapuram
KERALA |
9995352091
snehasusuzach@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PMS College of Dental Science and Research, Vattapara, Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M267||Dental alveolar anomalies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RANBAXY DECAMYCIN 2ML |
DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML - 2ML INTRAVENOUS |
| Intervention |
RANBAXY DECAMYCIN 2ML |
DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML - 2ML SUBMUCOSAL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study
Patients indicated for bilateral surgical extraction
Patients with an age group of 18-60 years
Individuals under ASA I and II |
|
| ExclusionCriteria |
| Details |
Reported allergy or hypersensitivity to dexamethasone, amoxicillin, metronidazole, and paracetamol or any of the product used in the study
ï‚· Patients with severe acute infections
ï‚· Women who are pregnant and lactating mothers
ï‚· Patients with diabetes
ï‚· Patients with immunosuppression medication |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the postoperative swelling after submucosal dexamethasone injection using modifed tape method on the 7th postoperative day
2. To assess the postoperative swelling after intravenous dexamethasone injection using modified tape method on the 7th postoperative day
3. TO compare the postoperative swelling after submucosal and intravenous dexamethasone injection on the 7th postoperative day |
1.To assess the postoperative swelling after submucosal dexamethasone injection using modifed tape method on the 7th postoperative day
2. To assess the postoperative swelling after intravenous dexamethasone injection using modified tape method on the 7th post operative day
3. TO compare the postoperative swelling after submucosal and intravenous dexamethasone injection on the 7th postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the postoperative pain after submucosal dexamethasone injection
2. To assess the postoperative mouth opening submucosal dexamethasone injection
3.To assess the postoperative pain after intravenous dexamethasone injection
4.To assess the postoperative mouth opening after intravenous dexamethasone injection
5. To compare the postoperative pain after using submucosal and intravenous dexamethasone injection |
1st and 7th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/09/2021 |
| 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="1"
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 is a Randomised control study to see the efficency of submucosal versus intravenous dexamethasone injection for the reduction of post operative sequlae like swelling,pain and mouth opening following the oral minor surgical procedures.
The primary objective will be assessment of postoperative swelling after submucosal and intravenous dexamethasone 2ml,8mg injection on the immediate post operative and post operative 7th day. The secondary objective is to assess the postoperative pain and mouth opening after submucosal and intravenous dexamethasone 2ml,8mg injection on the 1st and 7th day.
submucosal injection forbids the extra armamentarium and easy absorption due to the rich vascular supply in the site of pterygomandibular region and maxillary posterior buucal side. intravenous injection needs extra exoertise and armamentarium it will create more anxiety and pain to the patient and it can cause another complications like thrombophlebitis. |