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Completed

NCT Number: NCT07261761

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

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

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Key information

Conditions

Reversible Pulpitis Irreversible Pulpitis

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura Univeristy

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

vital pulp therapy

Procedure
  • Full medical and dental history will be taken from each patient.
  • Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth.
  • 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.
  • A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test.
  • 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.
  • Putty MTA will gently place over the pulp.
  • The cavity will be sealed with initial deep layer of resin modified glass ionomer restoration (RMGI) and final superficial layer of composite restoration.

extraction

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

blood sample collection

Procedure

after access opening blood sample will be collected

Primary outcomes

  1. Clinical success

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

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

Secondary outcomes

  1. Radiographic success

    Time frame: Pre-operative , and after six months

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

  2. level of cytokines

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

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: Pulp Therapy

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

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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