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CompletedNCT07592455CBCPABMGCFFIPTUpdated May 18, 2026

Correlation Between the Clinical Presentation of Pulp and the Biological Mediators in Gingival Crevicular Fluid and the Inflamed Pulpal Tissue

An interventional study of root canal treatment and samples from Gingival crevicular fluid in Irreversible Pulpitis (Toothache), sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The aim of the present study was to Correlate between the clinical presentation of pulp and the biological mediators in gingival crevicular fluid and the inflamed pulpal tissue.

02

Conditions studied

  • Irreversible Pulpitis (Toothache)

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03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's enrollment of 36 is below the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 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
18 Years to 50 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

Systemically healthy male and female individuals aged between 18 and 50 years

No physical or mental disabilities

No underlying systemic diseases

Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis with apical periodontitis

Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis without apical periodontitis

Diagnosis based on the terminology of the American Association of Endodontists (2009)

Patients who provided written

Fully developed teeth with no previous pulp exposure

Positive response to cold testing

Positive response to electric pulp testing

Exclusion criteria

Exclusion Criteria

Requirement for antibiotic prophylaxis

Diabetes or hematologic disorders

Use of anti-inflammatory drugs, antibiotics, or antidepressants within the previous four weeks

Pregnancy at the time of treatment

Heavy plaque or calculus accumulation

Gingival redness and bleeding

Severe gingivitis or generalized periodontitis

Gingival pocket depths greater than 3 mm

Negative response to sensibility testing (cold test or electric pulp testing)

Presence of apical radiolucency (PAI > 2)

Previously initiated endodontic treatment

Internal or external root resorption

History of trauma

Severe calcific metamorphosis with obliterated root canal spaces on periapical radiographs

Vertical root fractures

Mobility greater than Grade I (Miller's mobility index)

Swelling or sinus tract associated with the treated tooth

Presence of periodontal-endodontic lesions

Teeth that could not be properly isolated with a dental dam

Collection of less than 10 µL of blood from each site

Conflicting clinical and radiographic findings preventing clear group assignment

No bleeding from one or more canal orifices (possible partial necrosis)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    lower premolars

    root canal treatment and samples of biomarkers

    Procedure: root canal treatment · Diagnostic Test: samples from Gingival crevicular fluid

  • Active comparator
    control teeth / contralateral tooth

    samples of biomarkers

    Procedure: root canal treatment · Diagnostic Test: samples from Gingival crevicular fluid

Interventions

  • Procedureroot canal treatment

    root canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis

  • Diagnostic testsamples from Gingival crevicular fluid

    samples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth

06

What researchers measure

Primary outcomes

  1. biological markers level

    TNF-alpha and sub P

    Time frame: 2 months

Secondary outcomes

  1. Pain score through the Visual analogue scale

    where the minimum reading is 0 and the maximum reading is 10

    Time frame: 1 week

  2. clinical presentation of irreversible pulpitis

    Electric pulp tester

    Time frame: 1 week

07

Study locations

1 site
  • AinShams University
    Cairo, Cairo Governorate 12611, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07592455
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Sep 28, 2025
Primary completion
Nov 1, 2025
Completion
Dec 5, 2025
Last update
May 18, 2026

Oversight

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

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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