drugset / Trial / NCT07101016

Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling

NCT07101016

Not yet recruiting 44 enrolled Mariam Hesham Mahmoud Abdelfattah Eissa
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical trial is to evaluate whether locally applied diclofenac sodium, with or without hyaluronidase, can reduce post-surgical pain and swelling in adult male and female patients (18 years or older) with asymptomatic single-rooted teeth and periapical lesions (5-10 mm in diameter). The main questions it aims to answer are: Does local application of diclofenac sodium reduce postoperative pain and swelling compared to no medication? Does the combination of diclofenac sodium and hyaluronidase offer greater reduction in postoperative pain and swelling than diclofenac sodium alone? Researchers will compare four groups (diclofenac only, hyaluronidase only, diclofenac + hyaluronidase, and no medicament) to see if the medicated groups experience significantly less pain and swelling after periapical surgery compared to the control group. Participants will: Undergo root canal treatment followed by periapical surgery in a single visit. Receive a randomly assigned intra-osseous gel (diclofenac, hyaluronidase, both, or none) placed into the surgical cavity. Record their postoperative pain using a visual analogue scale at specified intervals (6, 12, 24, 48 hours, and 7 days). Return for clinical assessments of swelling at 24, 72 hours, and 5 days post-surgery

Timeline

Start
2025-08-01
Primary completion
2025-08-01
Completion
2025-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 75 mg Other
Subject rHuPH20 Protein / enzyme biologic 1500 iu Other