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

NCT07261761 | Completed

• 1 other identifier: M05060722
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Reversible Pulpitis; Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Clinical success

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

  one day, one, four and twelve weeks.

Secondary Outcomes (2)

• Radiographic success

  Pre-operative , and after six months

• level of cytokines

  through study completion, an average of 6 months

Study Arms (2)

Molars or premolars with Reversible or irreversible pulpits

EXPERIMENTAL

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

Procedure: Vital pulp therapy; Procedure: blood sample collection

Caries free molars or premolars

ACTIVE COMPARATOR

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

Procedure: Extraction; Procedure: blood sample collection

Interventions

Vital pulp therapy PROCEDURE

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.

Molars or premolars with Reversible or irreversible pulpits

Extraction PROCEDURE

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.

Caries free molars or premolars

blood sample collection PROCEDURE

after access opening blood sample will be collected

Caries free molars or premolars; Molars or premolars with Reversible or irreversible pulpits

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura Univeristy

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at faculty of dentistry Mansoura University

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 3, 2025
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: April 2, 2025
• Last Updated: December 3, 2025

Record last verified: 2022-07

Locations

EG (1)