Irreversible PulpitisPhase 1/2NCT07906925
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
A Phase 1/2 study testing Dexamethasone Sodium Phosphate 10 MG/ML and Sodium Hypochlorite 2,5% in people with Irreversible Pulpitis, run by Tanta University.
Trial summary
evaluate the antimicrobial efficacy of preheated sodium hypochlorite and dexamethasone sodium phosphate and at room temperature in patients with primary root canal infection. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Dexamethasone Sodium Phosphate 10 MG/ML and Sodium Hypochlorite 2,5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to 20 Nov 2026
- Phase
- Phase 1/2
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Vital/non vital single rooted teeth with single root canal with nearly the same apical diameter (#15) requiring root canal treatment.
- Teeth with sound periodontal apparatus.
- Teeth without pus or inflammatory exudates draining through the canal.
Who cannot join
- Teeth with anatomic anomilies.
- Teeth with calcified canals.
- Teeth with periapical lesions.
- Teeth with incompletely formed root apices.
- Retreatment cases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abelmoneim Ahmed Elkalashy, lecturer contact
About this study
evaluate the antimicrobial efficacy of preheated sodium hypochlorite and dexamethasone sodium phosphate and at room temperature in patients with primary root canal infection.
- Conditions
- Irreversible Pulpitis
- Being tested
- Dexamethasone Sodium Phosphate 10 MG/ML, Sodium Hypochlorite 2,5%
- Keywords
- Antimicrobial Efficacy, Temperature elevation
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate 10 MG/MLDrug
will be used in root canal irrigation
Sodium Hypochlorite 2,5%Other
will be used in root canal irrigation
| Study group | Role | What they receive |
|---|---|---|
| preheated sodium hypochlorite | Experimental | Not described Receives: Other: Sodium Hypochlorite 2,5% |
| preheated dexamethasone sodium phosphate | Active comparator | Not described Receives: Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
| sodium hypochlorite at room temperature | Experimental | Not described Receives: Other: Sodium Hypochlorite 2,5% |
| dexamethasone sodium phosphate at room temperature | Active comparator | Not described Receives: Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial culture for all samples will be done using two plates for each sample, one will be incubated aerobically and other anaerobically.
All microbial samples (S1, S2) will be managed in the laboratory at the department of microbiology ,faculty of medicine, Tanta university as follow; agitation of test tubes will be done for 30 seconds using vortex mixer. Two plates will be used for each specimen, one will be incubated aerobically and other anaerobically in anaerobic jar with adding anaerogen sachets to provide oxygen free media. Both plates will be incubated at 37°C for 24 hours and colony forming units (CFUs) will be counted after growth in these aerobic and anaerobic conditions
Measured: culture will be done immediately after the intervention,, culture result after 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start5 Oct 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdel Moneim Ahmed Elkalashy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906925
- Sponsor's protocol ID
- R-END-8-26-3294
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07906925
- Acronym / sponsor ID
- R-END-8-26-3294
- Conditions
- Irreversible Pulpitis
- Keywords
- Antimicrobial Efficacy, Temperature elevation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 30 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.
evaluate the antimicrobial efficacy of preheated sodium hypochlorite and dexamethasone sodium phosphate and at room temperature in patients with primary root canal infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| preheated sodium hypochlorite | Experimental | Other: Sodium Hypochlorite 2,5% |
| preheated dexamethasone sodium phosphate | Active comparator | Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
| sodium hypochlorite at room temperature | Experimental | Other: Sodium Hypochlorite 2,5% |
| dexamethasone sodium phosphate at room temperature | Active comparator | Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Vital/non vital single rooted teeth with single root canal with nearly the same apical diameter (#15) requiring root canal treatment.
Key exclusion criteria (5 listed)
- Teeth with anatomic anomilies.
- Teeth with calcified canals.
- Teeth with periapical lesions.
- Teeth with incompletely formed root apices.
- Retreatment cases
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 |
|---|---|---|
| Dexamethasone Sodium Phosphate 10 MG/MLwill be used in root canal irrigation | Drug | dexamethasone sodium phosphate at room temperature, preheated dexamethasone sodium phosphate |
| Sodium Hypochlorite 2,5%will be used in root canal irrigation | Other | preheated sodium hypochlorite, sodium hypochlorite at room temperature |
Primary outcome
microbial culture for all samples will be done using two plates for each sample, one will be incubated aerobically and other anaerobically.
Time frame: culture will be done immediately after the intervention,, culture result after 24 hours.
All microbial samples (S1, S2) will be managed in the laboratory at the department of microbiology ,faculty of medicine, Tanta university as follow; agitation of test tubes will be done for 30 seconds using vortex mixer. Two plates will be used for each specimen, one will be incubated aerobically and other anaerobically in anaerobic jar with adding anaerogen sachets to provide oxygen free media. Both plates will be incubated at 37°C for 24 hours and colony forming units (CFUs) will be counted after growth in these aerobic and anaerobic conditions
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 30 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.
Abelmoneim Ahmed Elkalashy, lecturer contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone Sodium Phosphate 10 MG/ML and Sodium Hypochlorite 2,5% in people with Irreversible Pulpitis, run by Tanta University.
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 3 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Abelmoneim Ahmed Elkalashy, lecturer (01005081823 ext. +2, abdelmoneim.elkalashy@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbial culture for all samples will be done using two plates for each sample, one will be incubated aerobically and other anaerobically. (time frame: culture will be done immediately after the intervention,, culture result after 24 hours.). 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 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.