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

Diagnostic Biomarkers to Correlate Molecular Changes and Early Inflammatory Cascade in Deep Carious Lesions With Dental Pulp Exposure.

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).

Study Overview

• Status: Completed
• Conditions: Vital Pulp Therapy
• Intervention / Treatment: Diagnostic test: Cytokines level in pulpal blood.; Procedure: Pulp therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Mansoura, Dakahliya, Egypt, 35511
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Diagnostic test: Cytokines level in pulpal blood.; Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.
Experimental: Direct Pulp Capping group	Diagnostic test: Cytokines level in pulpal blood.; Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.; Procedure: Pulp therapy; partial or complete removal of inflamed pulp tissue
Experimental: Partial Pulpotomy group	Diagnostic test: Cytokines level in pulpal blood.; Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.; Procedure: Pulp therapy; partial or complete removal of inflamed pulp tissue
Experimental: Complete Pulpotomy group	Diagnostic test: Cytokines level in pulpal blood.; Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.; Procedure: Pulp therapy; partial or complete removal of inflamed pulp tissue
Experimental: Root canal treatment group	Diagnostic test: Cytokines level in pulpal blood.; Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.; Procedure: Pulp therapy; partial or complete removal of inflamed pulp tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periradicular condition of the teeth	Presence of any radiographic abnormal periapical change	6 months
Level of Interleukin 8 in pulpal blood	Severity of inflammation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Matrix metalloproteinase 9 in pulpal blood	Cytokines level in pulpal blood	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cytokines; Partial Pulpotomy; Direct Pulp Capping
• Other Study ID Numbers: M02031120

Drug and device information, study documents

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