Pulp NecrosisNCT07897591
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
A study testing Metronidazole 0.5%, Nano-formulated Metronidazole 0.5% and Sodium Hypochlorite 2.5% in people with Pulp Necrosis and Apical Periodontitis, run by October 6 University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Pulp Necrosis, Apical Periodontitis
- What is being tested?
- Metronidazole 0.5%, Nano-formulated Metronidazole 0.5% and Sodium Hypochlorite 2.5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, October 6 University
Giza, Giza Governorate, 12511
Mariam S Abdelfattah, BDS, +201123242411, Samy04119@gmail.com
Mostafa S Shaker, PhD, +20 10 03053383
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Being tested
- Metronidazole 0.5%, Nano-formulated Metronidazole 0.5%, Sodium Hypochlorite 2.5%, Ultra X Ultrasonic Activation
- Keywords
- Root Canal Irrigation, Metronidazole, Nano-formulated Metronidazole, Ultrasonic Activation, Post-operative Pain, Endotoxin
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole 0.5%Drug
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%Drug
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%Drug
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.
Ultra X Ultrasonic ActivationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hypochlorite 2.5% Without Activation | Active comparator | Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation without ultrasonic activation Receives: Drug: Sodium Hypochlorite 2.5% |
| Sodium Hypochlorite 2.5% With Ultrasonic Activation | Active comparator | Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation followed by ultrasonic activation using the Ultra X device. Receives: Drug: Sodium Hypochlorite 2.5%; Device: Ultra X Ultrasonic Activation |
| Metronidazole 0.5% Without Activation | Experimental | Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation without ultrasonic activation. Receives: Drug: Metronidazole 0.5% |
| Metronidazole 0.5% With Ultrasonic Activation | Experimental | Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device. Receives: Drug: Metronidazole 0.5%; Device: Ultra X Ultrasonic Activation |
| Nano-formulated Metronidazole 0.5% Without Activation | Experimental | Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation without ultrasonic activation Receives: Drug: Nano-formulated Metronidazole 0.5% |
| Nano-formulated Metronidazole 0.5% With Ultrasonic Activation | Experimental | Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device. Receives: Drug: Nano-formulated Metronidazole 0.5%; Device: Ultra X Ultrasonic Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, 24, 48, and 72 hours postoperatively
Secondary outcomes (1)
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.
Measured: Baseline (before instrumentation) and immediately after completion of the final irrigation protocol during the same treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Oct 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to six parallel groups with an allocation ratio of 1:1:1:1:1:1
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Samy Abdelfattah, October 6 University
- Investigators
- Mostafa Shaker, PhD, Study chair, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897591
- Sponsor's protocol ID
- RECO6U/34-2026
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07897591
- Acronym / sponsor ID
- RECO6U/34-2026
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Keywords
- Root Canal Irrigation, Metronidazole, Nano-formulated Metronidazole, Ultrasonic Activation, Post-operative Pain, Endotoxin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be randomly allocated to six parallel groups with an allocation ratio of 1:1:1:1:1:1
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite 2.5% Without Activation | Active comparator | Drug: Sodium Hypochlorite 2.5%Participants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation without ultrasonic activation |
| Sodium Hypochlorite 2.5% With Ultrasonic Activation | Active comparator | Drug: Sodium Hypochlorite 2.5%, Device: Ultra X Ultrasonic ActivationParticipants will receive root canal irrigation using 2.5% sodium hypochlorite during instrumentation followed by ultrasonic activation using the Ultra X device. |
| Metronidazole 0.5% Without Activation | Experimental | Drug: Metronidazole 0.5%Participants will receive root canal irrigation using 0.5% metronidazole during instrumentation without ultrasonic activation. |
| Metronidazole 0.5% With Ultrasonic Activation | Experimental | Drug: Metronidazole 0.5%, Device: Ultra X Ultrasonic ActivationParticipants will receive root canal irrigation using 0.5% metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device. |
| Nano-formulated Metronidazole 0.5% Without Activation | Experimental | Drug: Nano-formulated Metronidazole 0.5%Participants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation without ultrasonic activation |
| Nano-formulated Metronidazole 0.5% With Ultrasonic Activation | Experimental | Drug: Nano-formulated Metronidazole 0.5%, Device: Ultra X Ultrasonic ActivationParticipants will receive root canal irrigation using 0.5% nano-formulated metronidazole during instrumentation followed by ultrasonic activation using the Ultra X device. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole 0.5%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. | Drug | Metronidazole 0.5% With Ultrasonic Activation, Metronidazole 0.5% Without Activation |
| Nano-formulated Metronidazole 0.5%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. | Drug | Nano-formulated Metronidazole 0.5% With Ultrasonic Activation, Nano-formulated Metronidazole 0.5% Without Activation |
| Sodium Hypochlorite 2.5%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. | Drug | Sodium Hypochlorite 2.5% With Ultrasonic Activation, Sodium Hypochlorite 2.5% Without Activation |
| Ultra X Ultrasonic ActivationUltrasonic 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. | Device | Metronidazole 0.5% With Ultrasonic Activation, Nano-formulated Metronidazole 0.5% With Ultrasonic Activation, Sodium Hypochlorite 2.5% With Ultrasonic Activation |
Primary outcome
Post-operative Pain Score
Time frame: 6, 12, 24, 48, and 72 hours postoperatively
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.
1 secondary outcome
Reduction in Endotoxin Levels
Time frame: Baseline (before instrumentation) and immediately after completion of the final irrigation protocol during the same treatment visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Shaker, PhD study chair
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole 0.5%, Nano-formulated Metronidazole 0.5% and Sodium Hypochlorite 2.5% in people with Pulp Necrosis and Apical Periodontitis, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam S Abdelfattah, BDS (01123242411, Samy04119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Score (time frame: 6, 12, 24, 48, and 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.