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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05464797
Collaborator
(none)
48
1
5
18.6
2.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulp therapy
  • Diagnostic Test: Cytokines level in pulpal blood.
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Diagnostic Biomarkers to Correlate Molecular Changes and Early Inflammatory Cascade in Deep Carious Lesions With Dental Pulp Exposure.
Actual Study Start Date :
Dec 12, 2020
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Procedure: Pulp therapy
partial or complete removal of inflamed pulp tissue

Diagnostic Test: Cytokines level in pulpal blood.
Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Experimental: Partial Pulpotomy group

Procedure: Pulp therapy
partial or complete removal of inflamed pulp tissue

Diagnostic Test: Cytokines level in pulpal blood.
Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Experimental: Complete Pulpotomy group

Procedure: Pulp therapy
partial or complete removal of inflamed pulp tissue

Diagnostic Test: Cytokines level in pulpal blood.
Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Experimental: Root canal treatment group

Procedure: Pulp therapy
partial or complete removal of inflamed pulp tissue

Diagnostic Test: Cytokines level in pulpal blood.
Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Outcome Measures

Primary Outcome Measures

  1. Periradicular condition of the teeth [6 months]

    Presence of any radiographic abnormal periapical change

  2. Level of Interleukin 8 in pulpal blood [6 months]

    Severity of inflammation

Secondary Outcome Measures

  1. Level of Matrix metalloproteinase 9 in pulpal blood [6 months]

    Cytokines level in pulpal blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Mansoura Dakahliya Egypt 35511

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05464797
Other Study ID Numbers:
  • M02031120
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mansoura University

Study Results

No Results Posted as of Jul 19, 2022