| CTRI Number |
CTRI/2024/11/076908 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing three types of drugs for post operative pain after third molar extraction |
|
Scientific Title of Study
|
Comparison of the effects of intra socket application of Ketamine, Tramadol and Diclofenac on post-operative pain after mandibular third molar surgery. A randomized control clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Choudhari |
| Designation |
Postgraduate student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth |
| Address |
Department of Oral and maxillofacial surgery, Ground floor
Indira Gandhi Institute of Dental Sciences, SBV campus, Pillaiarkuppam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9545378822 |
| Fax |
|
| Email |
akankshachoudhari20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghu K |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth |
| Address |
Department of Oral and maxillofacial surgery, Ground floor
Indira Gandhi Institute of Dental Sciences, SBV campus, Pillaiarkuppam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9043328474 |
| Fax |
|
| Email |
dr.raghuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Choudhari |
| Designation |
Postgraduate student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth |
| Address |
Department of oral and maxillofacial surgery, Ground floor
Indira Gandhi Institute of Dental Sciences, SBV campus, Pillaiarkuppam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9545378822 |
| Fax |
|
| Email |
akankshachoudhari20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Akanksha Choudhari, Department of Oral and maxillofacial surgery, Indira Gandhi Institute of Dental Sciences, SBV. |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Choudhari |
| Address |
Indira Gandhi Institute of Dental Sciences, SBV campus, Pillaiarkuppam, Pondicherry- 607402 |
| Type of Sponsor |
Other [] |
|
|
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 Akanksha Choudhari |
Indira Gandhi Institute of Dental Sciences |
Department of Oral and Maxillofacial surgery, Ground floor, IGIDS, SBV campus, Pillaiarkuppam, Pondicherry
Pondicherry
PONDICHERRY |
9545378822
akankshachoudhari20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Indira Gandhi Institute of Dental Scienes |
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 |
Inj. Ketamine 0.5 mg/kg diluted with 2ml saline |
Duration of the intervention 5 mins |
| Comparator Agent |
Inj. Tramadol 1 mg/kg diluted in 2 ml saline |
Duration of the intervention 5 mins |
| Intervention |
Inj.Diclofenac 1 mg/kg diluted with 2ml saline |
Duration of the intervention 5 mins |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with impacted mandibular third molar of pell and gregory class II level B |
|
| ExclusionCriteria |
| Details |
Patients with drug allergy, pregnant and lactating women, active infection, debilitating systemic illness, psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain post surgical extraction of impacted mandibular third molar |
1 hour 6 hours 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/11/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Will be provided after the data collection is completed
- For how long will this data be available start date provided 10-04-2025 and end date provided 10-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The objective of
this study is to compare the analgesic efficacy of intra
socket application of ketamine, tramadol and diclofenac on post operative
pain after mandibular third molar surgery by · Assessment
and comparison of pain by Visual Analogue Scale(VAS) for all the
groups after 1 hour, 6 hours and 24 hours postoperatively. · No of analgesic tablets
used in the first 24 hours for all the groups.
|