Diagnostic Biomarkers to Correlate Molecular Changes and Inflammatory Cascade in the Dental Pulp.

Mansoura University

Status: Completed

Conditions: Vital Pulp Therapy

Treatments: Procedure: Pulp therapy; Diagnostic Test: Cytokines level in pulpal blood.

Study type: Interventional

Funder types: Other

Identifiers

NCT05464797

M02031120

Details and patient eligibility

About

This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy).

Full description

The diagnosis of irreversible pulpitis was based only on the clinical signs and symptoms which does not always match that of the histological changes of the pulp tissues. So, it is more appropriate to diagnose the pulp according to the molecular changes taking place throughout the pulp tissues. Different studies have been conducted to study the molecular changes that take place in the inflamed pulp, Including a study that was conducted by Rechenberg et al in 2014 which states different locations to obtain samples for these molecules. The best of which was the dental pulp blood sample. Many studies stated the way to obtain a blood sample from the pulp and how to prepare and test it to evaluate the levels and concentrations of different inflammatory molecules. Many studies were also conducted to study the different changes and accurateness of measurement of different molecules.

The pulp inflammation occurs in a low compliance environment of dentinal walls. So, During acute inflammatory reaction, Vasodilatation occurs along with increased capillary permeability, Which leads to increase in the pulp interstitial fluid pressure which creates more pressure on blood vessels and this prevents beneficial blood flow, which decreases the ability of the pulp to defend itself from bacterial attacks causing tissue necrosis. This necrotic tissue is colonized by bacterial tissues.

In the literature, one of the novel treatment modalities for irrevesible inflammation of the pulp is partial removal of the inflammed pulp tissue according to clinical sign (bleeding control), The pulp tissue is removed partially until reaching complete coronal pulp removal or complete pulpectomy until hemostasis is obtained after 10 minutes of moist cotton pellet application.So, The normal pulp is preserved.

In 2019, Ricucci et al conducted a systematic review for treatment of deep carious lesions with pulp exposure. With treatment modalities ranging from direct pulp capping, partial pulpotomy, complete pulpotomy and pulpectomy. Based only on clinical signs of normal appearance of the pulp tissue under magnification with dental operating microscope and bleeding control within 10 minutes with a moist cotton pellet.

Enrollment: 48 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Positive response to cold testing.
• The age range from 15-45 years.
• Patients of both sex.
• Has clinical symptoms of pulpitis with normal apical tissues and supported by radiographic evaluation with no periradicular changes.

Exclusion criteria

• Patients over 45 years of age.
• Patients with clinical symptoms of periradicular inflammation or periradicular radiographic changes.
• Negative response to cold testing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 5 patient groups, including a placebo group

Control group

Placebo Comparator group

Treatment:

Diagnostic Test: Cytokines level in pulpal blood.

Direct Pulp Capping group

Experimental group

Treatment:

Procedure: Pulp therapy

Diagnostic Test: Cytokines level in pulpal blood.

Partial Pulpotomy group

Experimental group

Treatment:

Procedure: Pulp therapy

Diagnostic Test: Cytokines level in pulpal blood.

Complete Pulpotomy group

Experimental group

Treatment:

Procedure: Pulp therapy

Diagnostic Test: Cytokines level in pulpal blood.

Root canal treatment group

Experimental group

Treatment:

Procedure: Pulp therapy

Diagnostic Test: Cytokines level in pulpal blood.