| CTRI Number |
CTRI/2024/02/062947 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of efficacy of a new painkiller medicine namely Lornoxicam (extended release) and commonly used medicine Diclofenac for pain control following impacted wisdom teeth removal |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of single pre-emptive dose of Extended release Lornoxicam versus Prolonged release Diclofenac for surgical removal of impacted 3rd molar in Indian population: A prospective, randomized, triple blind, split mouth 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 Charudatta Naik |
| Designation |
Reader |
| Affiliation |
Department of Oral and Maxillofacial Surgery |
| Address |
Room no 131, Department of Oral and Maxillofacial Surgery, 1st Floor, Terna Dental College, Plot number 12, Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819014417 |
| Fax |
|
| Email |
csnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charudatta Naik |
| Designation |
Reader |
| Affiliation |
Department of Oral and Maxillofacial Surgery |
| Address |
Room no 131, Department of Oral and Maxillofacial Surgery, 1st Floor, Terna Dental College, Plot number 12, Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819014417 |
| Fax |
|
| Email |
csnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charudatta Naik |
| Designation |
Reader |
| Affiliation |
Department of Oral and Maxillofacial Surgery |
| Address |
Room no 131, Department of Oral and Maxillofacial Surgery, 1st Floor, Terna Dental College, Plot number 12, Sector 22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819014417 |
| Fax |
|
| Email |
csnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna Dental College
Plot No 12, Terna Campus Rd, opposite Railway Station, opposite Nerul West, Nerul |
|
|
Primary Sponsor
|
| Name |
Terna Dental College |
| Address |
Plot No 12, Terna Campus Rd, opposite Railway Station, opposite Nerul West, Nerul East, Sector 22, Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Research institution |
|
|
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 Charudatta Naik |
Terna Dental College |
Department of oral and maxillofacial surgery, Room no 131, Terna Dental College building, Plot No 12, Terna Campus Rd, opposite Railway Station, opposite Nerul West, Nerul East, Sector 22, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA |
9819014417
csnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College 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 |
| Comparator Agent |
Diclofenac |
Prolonged-Release formulation 100 mg administered orally, once daily for 3 days |
| Intervention |
Lornoxicam |
Lornoxicam Extended-Release formulation 16 mg administered orally, once daily for 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study
2.Patients requiring surgical extraction of bilateral impacted mandibular 3rd molar of similar difficulty (easy or moderate difficulty as per Pederson’s difficulty index)
3.Healthy patients belonging to ASA Class I or II will be included
4.Patients who are not on any pain management therapy or those who have not consumed any NSAID in the last seven days. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study
2.H/o Hypersensitivity reactions to Lornoxicam, Diclofenac or any other NSAID
3.Pregnant and lactating patients
4.Patients suffering from Bronchial Asthma or COPD or bleeding diathesis.
5.Patients with H/o gastritis, gastric/ duodenal ulcers, or any other inflammatory gastrointestinal disease
6.Pederson difficulty index score 7-10 (Difficult)
7.Patients having local signs of infection around the impacted tooth to be removed such as periapical abscess/granuloma, pericoronal abscess, fascial space infection etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain evaluation using modified visual analogue scale (0-10) |
4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swelling evaluation described by Gabka and Matsumara scale |
Postoperative Day 1 and Postoperative Day 3 |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
02/03/2024 |
| 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)
Modification(s)
|
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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [csnaik@gmail.com].
- For how long will this data be available start date provided 16-02-2024 and end date provided 16-02-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Research Question
Is there any difference in the efficacy of Lornoxicam extended-release formulation and diclofenac prolonged-release formulation in managing postoperative pain and swelling in impacted mandibular 3rd molar surgeries?
AIM
To compare the efficacy of single pre-emptive dose of Extended release Lornoxicam and Prolonged release Diclofenac for surgical removal of impacted mandibular 3rd molar.
Primary Objective
• To compare the efficacy of Extended release Lornoxicam and Prolonged release Diclofenac in managing PAIN following impacted mandibular 3rd molar removal.
Secondary Objective
• To compare the efficacy of Extended release Lornoxicam and Prolonged release Diclofenac in managing SWELLING following impacted mandibular 3rd molar removal. • To compare the time for 1st rescue analgesic in both the groups.
• To compare number of rescue analgesics needed in both the groups.
• To note the adverse events following administration of Lornoxicam ER and Diclofenac SR.
Null Hypothesis
There is no difference in the efficacy of extended release Lornoxicam and prolonged release Diclofenac in management of postoperative pain and swelling following impacted mandibular 3rd molar removal.
Alternative Hypothesis There is a difference in the efficacy of extended release Lornoxicam and prolonged release Diclofenac in management of postoperative pain and swelling following impacted mandibular 3rd molar removal. |