Conventional and nano-metronidazole irrigation with or without ultrasonic activation for necrotic single-rooted teeth with apical periodontitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, parallel-group trial compares three irrigants—2.5% sodium hypochlorite, 0.5% metronidazole, and 0.5% nano-formulated metronidazole—each tested with and without ultrasonic activation. The primary clinical outcome is post-operative pain measured on a visual scale at multiple time points after treatment; the biological outcome is the change in root canal endotoxin levels, quantified by ELISA. Sixty adults aged 21 to 50 with necrotic, single-rooted teeth and apical periodontitis will be enrolled and randomly assigned to six groups. Root canal preparation and irrigation will follow standardized procedures, and endotoxin levels will be collected before instrumentation and after the irrigation protocol. The trial aims to determine if nano-formulated metronidazole provides superior disinfection and symptom relief compared with conventional approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 21 and 50 years.
* Patients requiring non-surgical root canal treatment.
* Single-rooted permanent teeth with necrotic pulp.
* Teeth diagnosed with apical periodontitis.
* Teeth with fully formed apices.
* Patients medically free or with a controlled systemic condition.
* Patients able to understand the Visual Analogue Scale (VAS).

Exclusion Criteria:

* Patients with systemic diseases affecting healing, such as uncontrolled diabetes or immunocompromised patients.
* Patients who received antibiotics or anti-inflammatory drugs within the last 48 hours.
* Pregnant or lactating women.
* Previously endodontically treated teeth (retreatment cases).
* Teeth with root resorption, open apex, root fracture, or severe canal calcification.

Where it's running

• Faculty of Dentistry, October 6 University
  Giza, Giza Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Mariam S Abdelfattah, BDS
• Email: Samy04119@gmail.com
• Phone: 01123242411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.