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Completed

NCT Number: NCT05464797

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

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).

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Key information

Conditions

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulp therapy

Procedure

partial or complete removal of inflamed pulp tissue

Cytokines level in pulpal blood.

Diagnostic Test

Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.

Primary outcomes

  1. Periradicular condition of the teeth

    Time frame: 6 months

    Presence of any radiographic abnormal periapical change

  2. Level of Interleukin 8 in pulpal blood

    Time frame: 6 months

    Severity of inflammation

Secondary outcomes

  1. Level of Matrix metalloproteinase 9 in pulpal blood

    Time frame: 6 months

    Cytokines level in pulpal blood

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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