Effect of Conventional and Nano-Formulated Metronidazole as an Alternative Irrigant With and Without Activation on Post-operative Pain and Endotoxin Levels in Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Study
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 1, 2026
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2026
Actual (reported)October 17, 2026
Actual (reported)October 27, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
6, 12, 24, 48, and 72 hours postoperatively
Reduction in Endotoxin Levels
Baseline (before instrumentation) and immediately after completion of the final irrigation protocol during the same treatment visit.
Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation without ultrasonic activation
Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation followed by ultrasonic activation using the Ultra X device.
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.
Faculty of Dentistry, October 6 University
Giza, Giza Governorate, 12511, Egypt
Mostafa Shaker, PhD
October 6 University
First Submitted
October 17, 2026
First Posted
October 27, 2026
Study Start
October 1, 2026
Actual (reported)Postoperative Pain and PTN and Reciproc
Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain
Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation without ultrasonic activation.
Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device.
Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation without ultrasonic activation
Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device.
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.
Contact the study team to confirm eligibility.
Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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