A post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) / Paracetamol (325 mg) / Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery
- Conditions
- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,
- Registration Number
- CTRI/2022/01/039531
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
This trial is a prospective, randomized, open-label, two-arm, active-controlled, parallel, multicentre, post marketing clinical trial to assess the efficacy and safety of Enzoflam Tablet as compared to Zerodol-SP Tablet in patients with postoperative dental pain after third molar surgery. All the patients being prescribed the medication will be enrolled in the study. As this is a post marketing clinical trial to evaluate the efficacy and safety of the drug, free samples will be given to all the patients to ensure that the patients do not change the test product being used. After the third molar surgery, patients will be evaluated for all the eligibility criteria. Eligible patients will be administered with study medication & patient dairy card. Additionally, patients will be given rescue medication (Tramadol Tablets) which they will be allowed to take if they have unbearable pain even 2 hours after taking the study medication.
Patients will be instructed to take study medication one tablet twice daily (one in the morning and one in the evening). Also, patients will be trained on patient diary card to note down the pain intensity at various time points, dosage details such as date, time, dose, frequency of administration or missed dose. These details will be used to assess the treatment compliance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- Male and Female patients of age 18-45 years (both inclusive).
- Patients needing extraction for impacted third molars under local anaesthesia.
- Patients having moderate to severe pain at baseline (once surgery is over and local anaesthetic effect has subsided).
- Patients in general good health- American Society of Anaesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of outpatient conscious sedation).
- Patients willing to give written informed consent and comply with the study procedure.
- Patients with known hypersensitivity to any of the study drugs.
- Patients with any contraindication to the study drugs.
- Patients who are pregnant or nursing.
- Patients with history of peptic ulcers and/or GI bleeding.
- Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery).
- Patients developing any complication during or after surgery.
- Unusual surgical difficulty.
- Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
- Participation in another clinical trial in the past 1 month prior to screening.
- Any other reason for which the investigator feels that patient should not participate.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sum of pain intensity difference in 6 hours (SPID6) Sum of pain intensity difference in 6 hours (SPID6)
- Secondary Outcome Measures
Name Time Method 1. Total pain relief in 6 hours (TOTPAR6) 2. Time to onset of analgesia
Trial Locations
- Locations (2)
Dr. Ritus Dental Clinic
🇮🇳Ahmadabad, GUJARAT, India
Makhija Dental Clinic
🇮🇳Ahmadabad, GUJARAT, India
Dr. Ritus Dental Clinic🇮🇳Ahmadabad, GUJARAT, IndiaDr Ritu MehtaPrincipal investigator7600650300info@drritudentalclinic.com