Actively Recruiting
The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
Led by British University In Egypt · Updated on 2025-05-30
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the antibacterial effects of diclofenac sodium compared to calcium hydroxide paste when used as intracanal medications in permanent molar teeth affected by chronic apical periodontitis. The study focuses on whether diclofenac sodium, a type of nonsteroidal anti-inflammatory drug (NSAID), can effectively reduce bacteria similarly to calcium hydroxide during primary root canal treatment. Participants will be randomly assigned to one of three groups to receive different intracanal medications. The study involves three groups: one receiving a high concentration of diclofenac sodium mixed with saline, another receiving a low concentration mixed with saline, and a third group treated with calcium hydroxide paste. After cleaning and shaping the root canals, the assigned intracanal medication is placed and left inside the canal for one week. This treatment phase is followed by further evaluation and monitoring. Participants will have samples taken from their root canals before and after the medication placement to measure bacterial levels. Researchers will also assess healing of the periapical area via radiographic examination six months after treatment, monitor pain intensity using a visual scale at 24, 48, and 72 hours post-treatment, and record any flare-ups daily until the next visit after seven days. The main outcome measured is the bacterial count seven days after medication placement. The total study period includes follow-up assessments to evaluate treatment effects and safety.
CONDITIONS
Brief Title
The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with teeth diagnosed with apical periodontitis
- Periapical Index (PAI) score of 2 or higher
- The teeth are restorable
- Age between 18 and 50 years
You will not qualify if you...
- Teeth with immature roots
- Non-restorable teeth
- Medically compromised patients with systemic complications affecting treatment
- Teeth with internal or external root resorption
- Patients allergic to diclofenac sodium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants receive intracanal medication with either high or low concentration of diclofenac sodium or calcium hydroxide after cleaning and shaping of the root canals. The medication is left inside the root canals for one week.
2 visits (in-person): one for medication placement and one follow-up visit after 7 days
Duration - 6 months
Participants are recalled for radiographic examination to assess periapical healing six months after the obturation procedure. Pain intensity is assessed at 24, 48, and 72 hours after initial treatment, and flare-ups are monitored daily until the follow-up visit after seven days.
1 visit (in-person) for radiographic examination; pain assessed remotely at 24, 48, and 72 hours; daily flare-up monitoring until 7-day follow-up
Trial Site Locations
Total: 1 location
1
British university in Egypt
Cairo, Egypt
Actively Recruiting
Research Team
S
Summer M Elsayed, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here