An interventional study of Metronidazole 0.5% and Nano-formulated Metronidazole 0.5% in Pulp Necrosis and Apical Periodontitis, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by October 6 University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial evaluates the effect of conventional metronidazole and nano-formulated metronidazole as root canal irrigants, with and without ultrasonic activation, in patients with necrotic single-rooted teeth associated with apical periodontitis.
A total of 60 participants will be randomly allocated into six equal groups according to the irrigant used and whether ultrasonic activation is performed. Sodium hypochlorite will be used as the conventional control irrigant.
The study will compare the groups regarding post-operative pain and reduction in root canal endotoxin levels. Post-operative pain will be assessed using a Visual Analogue Scale, while endotoxin levels will be measured before and after treatment using an ELISA assay
Effective disinfection of the root canal system is an essential part of successful non-surgical root canal treatment. However, microorganisms and their by-products, including endotoxins, may persist within inaccessible areas of the root canal system and may contribute to post-operative pain and persistent periapical inflammation.
This single-center, randomized, controlled, parallel-group clinical trial is designed to compare conventional metronidazole and nano-formulated metronidazole irrigation with sodium hypochlorite in necrotic single-rooted teeth with apical periodontitis. The study also evaluates the effect of ultrasonic activation on the performance of each irrigant.
Sixty participants will be randomly allocated into six equal groups. The three irrigants evaluated are 2.5% sodium hypochlorite, 0.5% metronidazole, and 0.5% nano-formulated metronidazole. Each irrigant will be evaluated with and without ultrasonic activation using the Ultra X device. Root canal preparation and irrigation procedures will be standardized for all participants.
The primary clinical outcome is post-operative pain, assessed using a 0-to-10 Visual Analogue Scale at 6, 12, 24, 48, and 72 hours after treatment. The biological outcome is the change in root canal endotoxin levels. Samples will be collected before instrumentation and after completion of the irrigation protocol, and endotoxin levels will be quantified using an ELISA assay.
156 studies on the registry are indexed under Dental Pulp Necrosis; 42 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 146 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →October 6 University is the lead sponsor of 144 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation without ultrasonic activation
Drug: Sodium Hypochlorite 2.5%
Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation followed by ultrasonic activation using the Ultra X device.
Drug: Sodium Hypochlorite 2.5% · Device: Ultra X Ultrasonic Activation
Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation without ultrasonic activation.
Drug: Metronidazole 0.5%
Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device.
Drug: Metronidazole 0.5% · Device: Ultra X Ultrasonic Activation
Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation without ultrasonic activation
Drug: Nano-formulated Metronidazole 0.5%
Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device.
Drug: Nano-formulated Metronidazole 0.5% · Device: Ultra X Ultrasonic Activation
Metronidazole 0.5% solution will be used as a root canal irrigant during chemo-mechanical preparation, with or without ultrasonic activation according to the assigned study group.
Nano-formulated metronidazole 0.5% solution will be used as a root canal irrigant during chemo-mechanical preparation, with or without ultrasonic activation according to the assigned study group.
Sodium hypochlorite 2.5% solution will be used as the conventional gold-standard root canal irrigant during root canal preparation, with or without ultrasonic activation according to the assigned study group.
Ultrasonic activation of the assigned root canal irrigant will be performed using the Ultra X device (Eighteeth) for 30 seconds per cycle according to the manufacturer's instructions.
Post-operative Pain Score
Post-operative pain will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain.
Time frame: 6, 12, 24, 48, and 72 hours postoperatively
Reduction in Endotoxin Levels
Endotoxin levels will be quantified using an ELISA assay and expressed as endotoxin units per milliliter (EU/mL). Reduction will be calculated by comparing baseline and post-treatment values.
Time frame: Baseline (before instrumentation) and immediately after completion of the final irrigation protocol during the same treatment visit.
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.
Of 65 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 3 months is below that.
Counting every sponsor, half of 66 studies reached it within 16 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Metronidazole