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).
Parallel
Diclofenac Sodium Gel
DrugI1: Diclofenac sodium : 1 mL of gel, of 1 mL of 3 mL/75 mg Diclofenac sodium and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I2: Hyaluronidase : 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder in 2.5 mL of 0.9% sodium chloride, and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I3: Diclofenac sodium and Hyaluronidase: 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder and 1 ampoule (3 mL/75 mg) of Diclofenac sodium, Carbopol 940 gel base, will be passively placed in the osseous cavity
Postoperative pain intensity
Postoperative pain intensity measured at 6,12,24, 72 hours and 1 week post-surgical procedure: Each patient will receive a pain chart containing a 10-cm visual analogue scale (VAS), one for each time interval. The patient will be instructed to rate his/her pain level at the corresponding time interval on a 10-cm visual analogue scale (VAS), scored between 0 (no pain) and 10 (the most unbearable pain). Metin et al. (2018)
Postoperative swelling
Each patient will be asked to return for assessment of the swelling, after 24,72 hours and 5 days, which will be conducted by the operator and co-supervisor by comparing the patients initial photograph. The operator and co-supervisor will rate the swelling level at the corresponding time interval as mild (slight puffiness of gum, cheek, or chin but face not distorted), moderate (cheek or chin or both are visibly distorted), and severe (gross distortion of involved part). Morse et al., (1987), Silva et al.(2022)
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Mariam Hesham Mahmoud Abdelfattah Eissa
Lead sponsor
Cairo University
Sponsor institution
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