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

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis; Reversible Pulpitis
• Intervention / Treatment: Procedure: Vital pulp therapy; Procedure: blood sample collection; Procedure: Extraction

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Faculty of Dentistry, Mansoura Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Procedure: blood sample collection; after access opening blood sample will be collected
Active Comparator: Caries free molars or premolars; fifteen patients with intact human premolars planed for extraction for orthodontic reason	Procedure: blood sample collection; after access opening blood sample will be collected; Procedure: Extraction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	post operative pain on cold testing binary outcome (Yes or no)	one day, one, four and twelve weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic success	Cone Beam Computed Tomography CBCT radiographic Examination for any periodontal widening or any periapical radiolucency.	Pre-operative , and after six months
level of cytokines	level of Interleukin 8 and Interleukin 10 will be measured using Enzyme- Linked Immunosorbent assay (ELISA) Kit	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): April 2, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: M05060722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No