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CompletedNCT07261761Pulp TherapyUpdated Dec 3, 2025

Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy

An interventional study of Vital pulp therapy and Extraction in Reversible Pulpitis and Irreversible Pulpitis, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Oct 2022, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
16 Years to 45 Years
Sex
All
01

Study summary

intervention eligible patients with teeth diagnosed with reversible or irreversible pulpits will go for vital pulp therapy and the other group will be patients will go for extraction of caries free teeth for orthodontic reasons, blood samples will be collected from both groups to analyze the level of cytokines IL-8 and IL-10 and it's relation with the success of the pulp therapy

02

Conditions studied

  • Reversible Pulpitis
  • Irreversible Pulpitis
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 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
16 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The age ranges from 16-45 years medically free.
  • Tooth should be vital on cold testing.
  • Vital permanent premolar and molar on cold testing, with deep caries, subsequent pulp exposure and bleeding pulp tissue in all canals after complete pulpotomy.
  • Diagnosis is either reversible or irreversible pulpitis with/ without periapical rarefaction.
  • The tooth is restorable and free from advanced periodontal disease.
  • Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion criteria

Exclusion Criteria:

  • Patients over 45 years of age.
  • Patients with clinical symptoms of periradicular inflammation or any periradicular radiographic lesions.
  • Negative results for cold and electrical pulp testing
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Molars or premolars with Reversible or irreversible pulpits

    fifteen patients with carious teeth showing signs and symptoms of pulp inflammation

    Procedure: Vital pulp therapy · Procedure: blood sample collection

  • Active comparator
    Caries free molars or premolars

    fifteen patients with intact human premolars planed for extraction for orthodontic reason

    Procedure: Extraction · Procedure: blood sample collection

Interventions

  • ProcedureVital pulp therapy

    1. Full medical and dental history will be taken from each patient. 2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth. 3. After anesthesia, Rubber dam is applied and complete caries removal will be done, deeply inside the cavity, the excavation will be done using low speed hand piece and excavator. 4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test. 5. After exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) pulp vitality was confirmed by the presence of bleeding pulp tissue from all canals. 6. Putty MTA will gently place over the pulp. 7. The cavity will be sealed with initial deep layer of resin modified glass ionomer restoration (RMGI) and final superficial layer of composite restoration.

  • ProcedureExtraction

    1. Full medical and dental history will be taken from each patient. 2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth. 3. After anesthesia, Rubber dam is applied. 4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test. 5. Extraction for orthodontic reasons.

  • Procedureblood sample collection

    after access opening blood sample will be collected

06

What researchers measure

Primary outcomes

  1. Clinical success

    post operative pain on cold testing binary outcome (Yes or no)

    Time frame: one day, one, four and twelve weeks.

Secondary outcomes

  1. Radiographic success

    Cone Beam Computed Tomography CBCT radiographic Examination for any periodontal widening or any periapical radiolucency.

    Time frame: Pre-operative , and after six months

  2. level of cytokines

    level of Interleukin 8 and Interleukin 10 will be measured using Enzyme- Linked Immunosorbent assay (ELISA) Kit

    Time frame: through study completion, an average of 6 months

07

Study locations

1 site
  • Faculty of Dentistry, Mansoura Univeristy
    Al Mansurah, 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 Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07261761
Lead sponsor
Mansoura University
Responsible party
Mohamed Khalifa (Researcher at faculty of dentistry Mansoura University, Mansoura University) — Principal investigator
First posted
Dec 3, 2025
Start date
Oct 1, 2022
Primary completion
Oct 1, 2024
Completion
Apr 2, 2025
Last update
Dec 3, 2025

Oversight

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

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