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
Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II, with no known allergic manifestations to the drugs used in the study and no involvement with other medication during the study (Appendix 2).
Patients who are 18 years of age or older, without underlying chronic systemic conditions.
Male and female patients.
Patients having asymptomatic single rooted teeth with periapical lesions 5-10mm in diameter (Appendix 3).
1. Teeth with pathosis associated with vertical root fractures, teeth with coronal perforations, and periodontal pockets (7 mm).
Mariam Hesham Mahmoud Abdelfattah Eissa
Lead sponsor
Cairo University
Sponsor institution