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Not yet recruitingNCT07906925Updated Oct 30, 2026

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 interventional study of Dexamethasone Sodium Phosphate 10 MG/ML and Sodium Hypochlorite 2,5% in Irreversible Pulpitis, sponsored by Tanta University. Not yet recruiting. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
15 Years to 45 Years
Sex
All
01

Study summary

evaluate the antimicrobial efficacy of preheated sodium hypochlorite and dexamethasone sodium phosphate and at room temperature in patients with primary root canal infection.

02

Conditions studied

  • Irreversible Pulpitis

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Keywords

  • Antimicrobial Efficacy
  • Temperature elevation
03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 40 is below the median of 123 across 271 interventional studies indexed under Fever.

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Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Teeth with anatomic anomilies.
  • Teeth with calcified canals.
  • Teeth with periapical lesions.
  • Teeth with incompletely formed root apices.
  • Retreatment cases
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    preheated sodium hypochlorite

    Other: Sodium Hypochlorite 2,5%

  • Active comparator
    preheated dexamethasone sodium phosphate

    Drug: Dexamethasone Sodium Phosphate 10 MG/ML

  • Experimental
    sodium hypochlorite at room temperature

    Other: Sodium Hypochlorite 2,5%

  • Active comparator
    dexamethasone sodium phosphate at room temperature

    Drug: Dexamethasone Sodium Phosphate 10 MG/ML

Interventions

  • DrugDexamethasone Sodium Phosphate 10 MG/ML

    Drug page: Dexamethasone phosphate

    will be used in root canal irrigation

  • OtherSodium Hypochlorite 2,5%

    will be used in root canal irrigation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: culture will be done immediately after the intervention,, culture result after 24 hours.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 30, 2026
StartEst.
Oct 5, 2026
Primary completionEst.
Oct 30, 2026
CompletionEst.
Nov 20, 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07906925
Lead sponsor
Tanta University
Responsible party
Abdel Moneim Ahmed Elkalashy (Dr. Abdel Moneim Ahmed Elkalashy, Tanta University) — Principal investigator
First posted
Oct 30, 2026
Start date
Oct 5, 2026 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Nov 20, 2026 (estimated)
Last update
Oct 30, 2026

Study contacts

Abelmoneim Ahmed Elkalashy, lecturer
Contact
abdelmoneim.elkalashy@dent.tanta.edu.eg
01005081823 ext. +2

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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