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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261761
Acronym
Pulp Therapy
Enrollment
40
Registered
2025-12-03
Start date
2022-10-01
Completion date
2025-04-02
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversible Pulpitis, Irreversible Pulpitis

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

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical successone day, one, four and twelve weeks.post operative pain on cold testing binary outcome (Yes or no)

Secondary

MeasureTime frameDescription
Radiographic successPre-operative , and after six monthsCone Beam Computed Tomography CBCT radiographic Examination for any periodontal widening or any periapical radiolucency.
level of cytokinesthrough study completion, an average of 6 monthslevel of Interleukin 8 and Interleukin 10 will be measured using Enzyme- Linked Immunosorbent assay (ELISA) Kit

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026