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

NCT ID: NCT07261761

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-04-02

Brief Summary

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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

Detailed Description

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Conditions

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Reversible Pulpitis Irreversible Pulpitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Molars or premolars with Reversible or irreversible pulpits

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

Group Type EXPERIMENTAL

Vital pulp therapy

Intervention Type 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.

blood sample collection

Intervention Type PROCEDURE

after access opening blood sample will be collected

Caries free molars or premolars

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

Group Type ACTIVE_COMPARATOR

Extraction

Intervention Type 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.

blood sample collection

Intervention Type PROCEDURE

after access opening blood sample will be collected

Interventions

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Vital 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.

Intervention Type PROCEDURE

Extraction

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.

Intervention Type PROCEDURE

blood sample collection

after access opening blood sample will be collected

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Khalifa

Researcher at faculty of dentistry Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Mansoura Univeristy

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M05060722

Identifier Type: -

Identifier Source: org_study_id

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