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

• 1 other identifier: 14422023572518
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Root End Resection; Periapical Lesion; Single Rooted Teeth

Keywords

Periapical lesion; Single rooted teeth; Post operative pain; Post operative swelling; Root end resection; Hyaluronidase; Diclofenac Sodium

Outcome Measures

Primary Outcomes (1)

• 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)

  6,12,24, 72 hours and 1 week post-surgical procedure

Secondary Outcomes (1)

• Postoperative swelling

  24,72 hours and 5 days

Study Arms (2)

No medication

NO INTERVENTION

Osseous cavity left with no medication after root end resection

Different types of medications placed in the osseous cavity after root end resection

EXPERIMENTAL

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

Drug: Diclofenac Sodium Gel

Interventions

Diclofenac Sodium Gel DRUG

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

Different types of medications placed in the osseous cavity after root end resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients who can understand the visual analogue scale (Appendix 4).
• Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).

You may not qualify if:

• \. Teeth with pathosis associated with vertical root fractures, teeth with coronal perforations, and periodontal pockets (7 mm).
• \. Miller class III/IV mobility, compromised crown-to-root ratio, combined endodontic-periodontic lesions 3. Systemic medical diseases and autoimmune diseases 4. Pregnant females 5. Patients allergic to Diclofenac or Hyaluronidase 6. Teeth with previous root canal therapy

Sponsors & Collaborators

• Mariam Hesham Mahmoud Abdelfattah Eissa: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mariam Hesham Mahmoud Eissa, MSc

CONTACT

00201001714432; mariam.abdelfattah@dentisrty.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 8, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share