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NOT YET RECRUITING
NCT07101016
NA

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

Sponsor: Mariam Hesham Mahmoud Abdelfattah Eissa

View on ClinicalTrials.gov

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

Official title: Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-08-01

Completion Date

2025-08-08

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

Diclofenac Sodium Gel

I1: 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