| CTRI Number |
CTRI/2025/07/090367 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of pre operative and post operative Lornoxicam in surgical removal of mandibular third molar |
|
Scientific Title of Study
|
Comparison of efficacy of pre-emptive and post operative lornoxicam in mandibular third molar surgeries - A split mouth study. |
| 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 Bhavana G Ammanagi |
| Designation |
Post Graduate Research Scholar |
| Affiliation |
Raja Rajeswari dental college and hospital, Bangalore |
| Address |
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9108706071 |
| Fax |
|
| Email |
bhavanaammanagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narahari Ranganatha |
| Designation |
Professor |
| Affiliation |
Raja Rajeswari dental college and hospital, Bangalore |
| Address |
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9342519662 |
| Fax |
|
| Email |
narahari2012@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana G Ammanagi |
| Designation |
Post Graduate Research Scholar |
| Affiliation |
Raja Rajeswari dental college and hospital, Bangalore |
| Address |
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore Karnataka India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9108706071 |
| Fax |
|
| Email |
bhavanaammanagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore 560074 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Bhavana G Ammanagi |
| Address |
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore 560074 Karnataka India |
| 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 Bhavana G Ammanagi |
Raja Rajeswari dental college and hospital Bangalore |
Department of Oral and Maxillofacial surgery
Raja Rajeswari dental college and hospital No 14 Ramohalli cross Kumbalagodu Mysore road
Bangalore 560074 Karnataka India
Bangalore Rural
KARNATAKA |
9108706071
bhavanaammanagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Raja Rajeswari dental college and hospital |
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 |
Tablet Lornoxicam 8 mg |
Tablet Lornoxicam 8 mg given one hour post operatively. |
| Intervention |
Tablet Lornoxicam 8 mg |
Tablet Lornoxicam 8 mg given one hour pre operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with bilaterally similar impacted mandibular third molars.
2) Patients classified under ASA I and ASA II requiring surgical extraction of bilaterally similar impacted mandibular third molars.
3) Patient willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patients with erupted third molars.
2) Patients classified under ASA III and ASA IV.
3) Patients who have consumed any other analgesics in 24 hours before surgery.
4) Patients with gastritis and peptic ulcers.
5) Pregnant patients.
6) Patients with psychiatric illness.
7) Patients with infections like pericoronitis, pericoronal abscess, etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The efficacy of Lornoxicam as a pre emptive and post operative analgesic.
2) Post operative pain
3) The number of rescue analgesics taken within 24 hours of the procedure.
4) Patient satisfaction by Likert scale. |
1)The efficacy of Lornoxicam as a pre emptive analgesic.
2)The efficacy of Lornoxicam as a post operative analgesic.
3)Pain at 2nd, 4th, 6th, 12th, and 24th hour post operatively using VAS.
4)The number of rescue analgesics taken within 24 hours of the procedure.
5)The patient satisfaction by Likert scale on 7th follow up day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) The effectiveness of Lornoxicam as a pre emptive analgesic.
2) The effectiveness of Lornoxicam as a post operative analgesic.
3) Post operative pain
4) The number of rescue analgesics taken.
5) Patient satisfaction by Likert scale. |
1)The efficacy of Lornoxicam as a pre emptive analgesic.
2)The efficacy of Lornoxicam as a post operative analgesic.
3)Pain at 2nd, 4th, 6th, 12th, & 24th hour post operatively using VAS.
4)The number of rescue analgesics taken within 24 hours of the procedure.
5)The patient satisfaction by Likert scale on 7th follow up 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining approval and clearance from the Institutional Ethical Committee the patients fulfilling the inclusion criteria will be enrolled for the study. Patients requiring surgical removal of impacted third molars on mandibular arch are taken up after radiographical assessment is done. Surgical site will be randomly divided into two groups Group A will receive tablet Lornoxicam eight mg one hour before the surgery and Group B will receive tablet Lornoxicam eight mg one hour after the surgery. Patient will be asked to rinse the oral cavity thoroughly and standard painting and draping of the patient will be done. The procedure will be performed under Local anesthesia two percent lignocaine with adrenaline. Classical inferior alveolar nerve block will be given. Once the anesthesia is achieved surgical assess will be gained. Bone will be removed around the tooth under copious irrigation. The crown and roots will be sectioned if necessary. Third molar will be removed surgically with minimal trauma to investing tissues. Socket toileting will be done followed by primary closure. Antibiotics and Analgesics will be prescribed post operatively. Post operative instructions will be given and is instructed to consume first rescue analgesic tablet Lornoxicam eight mg as soon as the patient experiences pain. The patient will be assessed for pain post operative hours through questionnaire. Patient satisfaction will be recorded using Likert five point scale post operatively |