Health Condition 1: K011- Impacted teeth
Conditions
Interventions
Intervention1: Zerodol-SP: Aceclofenac 100mg plus paracetamol 325mg plus serratiopeptidase 15mg
Total duration of the treatment will be 07 days
Control Intervention1: Zerodol-P: Aceclofenac 100mg pl
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient undergoing surgery for extraction of lower 3rd molar 2. Patients having first and second molars on the side of the surgery 3. Patients with ASA Grade 1 4. Patients with no history of oral surgical interventions during the past 3 weeks 5. Patients able to understand and willing to fully comply with study procedures and restrictions. 6. Patient ready to give informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients with Type 1 diabetes / Type 2 Diabetes 2. Patients with hypertension (SBP=140 mmHg and/or DBP =90 mmHg) 3. Patients with genetically transmitted bleeding disorders 4. Patients with pathologic changes in teeth or the surrounding area 5. Patients with extraoral or intraoral swelling with cellulitis in the area of surgery 6. Patients with history of systemic illness 7. Patients with respiratory depression, asthma or other breathing problems 8. Patients with cardiac disease 9. Patients with previous or present gastric ulcers 10. Patients with abnormal renal function (serum creatinine =1.5 mg/dL for male and =1.4 mg/dL for female) 11. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active or chronic liver disease 12. Patients with significantly abnormal counts in hematology, diseases of blood or hematopoietic organs or female patients with Hb 13. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer) 14. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents 15. Patients with malabsorption or pancreatitis 16. Patients with dementia or other cognitive impairment prohibiting informed consent 17. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection 18. Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation 19. Patients suspected of COVID-19 infection 20. Patients who have taken analgesic or anti-inflammatory drugs within 48 hours before surgery 21. Patients with chronic use of non-steroidal anti-inflammatory agents 22. Patients receiving concomitant medications known to have an interaction with study medications 23. Patients receiving anti-coagulant drugs 24. Patients with known history of hypersensitivity to study drugs or drugs of same chemical class or any other ingredient of the study formulations or with history of any severe allergic disease 25. Patients with other substance abuse within last 1 year 26. Patients consuming alcohol more than 21 units /week 27. Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment. 28. Pregnant or lactating women 29. Women of childbearing potential not practicing contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean swelling of face by measuring distance in millimeters from the bottom edge of the earlobe to the midpoint of symphysia hirota (chin; DHS), distance in millimeters from bottom edge of the earlobe to external angle of mouth (horizontal distance to the corner of mouth; DHC), distance in millimeters from the palpebral outboard angle to gonial angle (verticle distance; DV)Timepoint: at post-operative day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| mean cheek swelling between treatment groupsTimepoint: at post-operative days 1, 2, 3, 5, and 7.;mean pain intensity between treatment groupsTimepoint: at post-operative Days 1, 2, 3, 5, and 7;mean swelling (based on individual distance; DHS, DHC, and DV) between treatment groupsTimepoint: at post-operative Day 1, 2, 3, 5 and 7 from baseline;mean swelling (Facial measurements; DHS, DHV and DV) between treatment groupsTimepoint: at post-operative Day 1, 2, 3 and 5 from baseline;trismus between treatment groupsTimepoint: at post-operative Days 1, 2, 3, 5, and 7. | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed