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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07592455
Acronym
CBCPABMGCFFIPT
Enrollment
36
Registered
2026-05-18
Start date
2025-09-28
Completion date
2025-12-05
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis (Toothache)

Brief 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.

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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 informed consent Fully developed teeth with no previous pulp exposure Positive response to cold testing Positive response to electric pulp testing

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)

Design outcomes

Primary

MeasureTime frameDescription
biological markers level2 monthsTNF-alpha and sub P

Secondary

MeasureTime frameDescription
Pain score through the Visual analogue scale1 weekwhere the minimum reading is 0 and the maximum reading is 10
clinical presentation of irreversible pulpitis1 weekElectric pulp tester

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026