Irreversible Pulpitis (Toothache)CBCPABMGCFFIPTNCT07592455
Correlation Between the Clinical Presentation of Pulp and the Biological Mediators in Gingival Crevicular Fluid and the Inflamed Pulpal Tissue
A study testing root canal treatment and samples from Gingival crevicular fluid in people with Irreversible Pulpitis (Toothache), run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irreversible Pulpitis (Toothache)
- What is being tested?
- root canal treatment and samples from Gingival crevicular fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2025to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Irreversible Pulpitis (Toothache)
- Being tested
- root canal treatment, samples from Gingival crevicular fluid
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatmentProcedure or surgery
root canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis
samples from Gingival crevicular fluidDiagnostic test
samples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth
| Study group | Role | What they receive |
|---|---|---|
| lower premolars | Experimental | root canal treatment and samples of biomarkers Receives: Procedure: root canal treatment; Diagnostic Test: samples from Gingival crevicular fluid |
| control teeth / contralateral tooth | Active comparator | samples of biomarkers Receives: Procedure: root canal treatment; Diagnostic Test: samples from Gingival crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological markers level
TNF-alpha and sub P
Measured: 2 months
Secondary outcomes (2)
Pain score through the Visual analogue scale
where the minimum reading is 0 and the maximum reading is 10
Measured: 1 week
clinical presentation of irreversible pulpitis
Electric pulp tester
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start28 Sep 2025
- Primary completion1 Nov 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (Toothache)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592455
- Sponsor's protocol ID
- 567890111213141516171819202122
- Other IDs
- Ain Shams University
- Acronym
- CBCPABMGCFFIPT
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Clinical Presentation of Pulp and the Biological Mediators in Gingival Crevicular Fluid and the Inflamed Pulpal Tissue
- ClinicalTrials.gov ID
- NCT07592455
- Acronym / sponsor ID
- CBCPABMGCFFIPT / 567890111213141516171819202122
- Conditions
- Irreversible Pulpitis (Toothache)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 18 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lower premolars | Experimental | Procedure: root canal treatment, Diagnostic Test: samples from Gingival crevicular fluidroot canal treatment and samples of biomarkers |
| control teeth / contralateral tooth | Active comparator | Procedure: root canal treatment, Diagnostic Test: samples from Gingival crevicular fluidsamples of biomarkers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| root canal treatmentroot canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis | Procedure or surgery | control teeth / contralateral tooth, lower premolars |
| samples from Gingival crevicular fluidsamples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth | Diagnostic test | control teeth / contralateral tooth, lower premolars |
Primary outcome
biological markers level
Time frame: 2 months
TNF-alpha and sub P
2 secondary outcomes
Pain score through the Visual analogue scale
Time frame: 1 week
clinical presentation of irreversible pulpitis
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment and samples from Gingival crevicular fluid in people with Irreversible Pulpitis (Toothache), run by Ain Shams University at 1 site in Egypt.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological markers level (time frame: 2 months). 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 18 May 2026.