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OpenTrials
Completed

NCT Number: NCT07592455

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AinShams University

Cairo, Cairo Governorate, 12611, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Root canal treatment

Procedure

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

samples from Gingival crevicular fluid

Diagnostic Test

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

Primary outcomes

  1. biological markers level

    Time frame: 2 months

    TNF-alpha and sub P

Secondary outcomes

  1. Pain score through the Visual analogue scale

    Time frame: 1 week

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

  2. clinical presentation of irreversible pulpitis

    Time frame: 1 week

    Electric pulp tester

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: CBCPABMGCFFIPT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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