Pulp NecrosisNCT07435883
Antibacterial Effect and Postoperative Pain After Triton Irrigation Protocol in Necrotic Mandibular Molar
A study testing triton irrigation protocol and conventional irrigation group in people with Pulp Necrosis, run by sara hosny mostafa at 1 site in Egypt.
Trial summary
This randomized clinical study evaluates the antibacterial effectiveness and postoperative pain following root canal irrigation using the Triton irrigation protocol in necrotic mandibular molars. Thirty-six patients requiring root canal treatment will be included. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- triton irrigation protocol and conventional irrigation group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2026to Oct 2026
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-45 years with no sex predilection
- Medically free Patients with no systemic conditions that can affect post operative pain response.
- Patients should not be taking any pain medications 24 hours before intervention
- Positive patients' acceptance for participating in the study
- Patient able to sign informed consent
- Permanent mandibular molars diagnosis with pulpal necrosis with asymptomatic apical periodontitis.
- Mandibular molars without any anatomical variations or severe curvatures with mesial roots configuration weine class 3 and a distal root with 2 distal canals
Who cannot join
- Medically compromised patients
- Patients who have received antibiotic therapy within the last 2 weeks.
- Pregnant or lactating women.
- Patients with known allergy to any of the irrigants used.
- Patients with swelling or acute peri-apical abscess or fistulous tract.
- Teeth that have:
- Wide or open apex .
- Vital pulp tissue .
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
Faculty of Oral and Dental Medicine , Future University in Egypt
Cairo, New Cairo, 11835
sara hosny mostafa adly, BDS, 00201009568678, drsarahosny45@yahoo.com
reham hassan, PHD
About this study
Official title: Evaluation of Antibacterial Effect and Postoperative Pain Following Irrigation Protocol Using Triton in Necrotic Mandibular Molars. A Randomized Clinical Control Trial
This randomized clinical study evaluates the antibacterial effectiveness and postoperative pain following root canal irrigation using the Triton irrigation protocol in necrotic mandibular molars. Thirty-six patients requiring root canal treatment will be included. The study aims to compare bacterial reduction and postoperative pain outcomes after treatment. Results may help improve irrigation protocols and patient comfort during endodontic therapy.
Read the detailed description
Root canal disinfection is a critical factor affecting the success of endodontic treatment, especially in teeth with necrotic pulps. Irrigation protocols play an essential role in reducing bacterial load inside the root canal system. The Triton irrigation protocol has been introduced to enhance antimicrobial effectiveness and improve debris removal.
This randomized clinical trial will include 36 patients diagnosed with necrotic mandibular molars indicated for root canal treatment. Participants will receive treatment following the assigned irrigation protocol. Bacterial samples will be collected before and after irrigation to evaluate antibacterial effectiveness. Postoperative pain will be assessed using a standardized pain scale during the follow-up period.
The findings of this study are expected to provide clinical evidence regarding the effectiveness of the Triton irrigation protocol in improving disinfection outcomes and reducing postoperative discomfort
- Conditions
- Pulp Necrosis
- Being tested
- triton irrigation protocol, conventional irrigation group
- Keywords
- root canal treatment, endodontics, irrigation protocol, triton irrigation, postoperative pain, antibacterial effect
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triton irrigation protocolProcedure or surgery
Root canal irrigation performed using Triton solution according to a standardized endodontic irrigation protocol during root canal treatment.
conventional irrigation groupProcedure or surgery
Participants receive conventional root canal irrigation using standard irrigation solutions during chemo-mechanical preparation according to the routine clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| triton group | Experimental | Participants receive root canal treatment using the Triton irrigation protocol for disinfection of necrotic mandibular molars. The protocol is applied according to the manufacturer's instructions during chemo-mechanical preparation. Receives: Procedure: triton irrigation protocol |
| conventional irrigation group | Active comparator | Participants receive root canal treatment using conventional syringe irrigation with sodium hypochlorite during chemo-mechanical preparation. Receives: Procedure: conventional irrigation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibacterial effect
Reduction in bacterial count will be evaluated by microbiological sampling before and after irrigation.
Measured: immediately after irrigation procedures
Secondary outcomes (1)
postoperative pain intensity
Postoperative pain will be assessed using a Visual Analog Scale (VAS) following root canal treatment with different irrigation protocols.
Measured: 6, 12, 24, and 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sara hosny mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sara hosny mostafa, Future University in Egypt
- Investigators
- sara hosny mostafa adly, BDS, Principal investigator, faculty of oral and dental medicine , future university in egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435883
- Sponsor's protocol ID
- FUE.REC (17)/1-2026
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibacterial Effect and Postoperative Pain Following Irrigation Protocol Using Triton in Necrotic Mandibular Molars. A Randomized Clinical Control Trial
- ClinicalTrials.gov ID
- NCT07435883
- Acronym / sponsor ID
- FUE.REC (17)/1-2026
- Conditions
- Pulp Necrosis
- Keywords
- root canal treatment, endodontics, irrigation protocol, triton irrigation, postoperative pain, antibacterial effect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- sara hosny mostafaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Feb 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 clinical study evaluates the antibacterial effectiveness and postoperative pain following root canal irrigation using the Triton irrigation protocol in necrotic mandibular molars. Thirty-six patients requiring root canal treatment will be included. The study aims to compare bacterial reduction and postoperative pain outcomes after treatment. Results may help improve irrigation protocols and patient comfort during endodontic therapy.
Detailed description
Root canal disinfection is a critical factor affecting the success of endodontic treatment, especially in teeth with necrotic pulps. Irrigation protocols play an essential role in reducing bacterial load inside the root canal system. The Triton irrigation protocol has been introduced to enhance antimicrobial effectiveness and improve debris removal.
This randomized clinical trial will include 36 patients diagnosed with necrotic mandibular molars indicated for root canal treatment. Participants will receive treatment following the assigned irrigation protocol. Bacterial samples will be collected before and after irrigation to evaluate antibacterial effectiveness. Postoperative pain will be assessed using a standardized pain scale during the follow-up period.
The findings of this study are expected to provide clinical evidence regarding the effectiveness of the Triton irrigation protocol in improving disinfection outcomes and reducing postoperative discomfort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triton group | Experimental | Procedure: triton irrigation protocolParticipants receive root canal treatment using the Triton irrigation protocol for disinfection of necrotic mandibular molars. The protocol is applied according to the manufacturer's instructions during chemo-mechanical preparation. |
| conventional irrigation group | Active comparator | Procedure: conventional irrigation groupParticipants receive root canal treatment using conventional syringe irrigation with sodium hypochlorite during chemo-mechanical preparation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18-45 years with no sex predilection
- Medically free Patients with no systemic conditions that can affect post operative pain response.
- Patients should not be taking any pain medications 24 hours before intervention
- Positive patients' acceptance for participating in the study
- Patient able to sign informed consent
Key exclusion criteria (8 listed)
- Medically compromised patients
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 |
|---|---|---|
| triton irrigation protocolRoot canal irrigation performed using Triton solution according to a standardized endodontic irrigation protocol during root canal treatment. | Procedure or surgery | triton group |
| conventional irrigation groupParticipants receive conventional root canal irrigation using standard irrigation solutions during chemo-mechanical preparation according to the routine clinical protocol. | Procedure or surgery | conventional irrigation group |
Primary outcome
antibacterial effect
Time frame: immediately after irrigation procedures
Reduction in bacterial count will be evaluated by microbiological sampling before and after irrigation.
1 secondary outcome
postoperative pain intensity
Time frame: 6, 12, 24, and 48 hours after treatment
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 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and privacy.
Related trials for Pulp Necrosis
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
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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.
sara hosny mostafa adly, BDS principal investigator
faculty of oral and dental medicine , future university in egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triton irrigation protocol and conventional irrigation group in people with Pulp Necrosis, run by sara hosny mostafa 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 8 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: opening soon, as of the sponsor's last update on 27 Feb 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 sara hosny mostafa adly, BDS (00201009568678, drsarahosny45@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibacterial effect (time frame: immediately after irrigation procedures). 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 Feb 2026.