Image

Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )

Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )

Recruiting
18-60 years
All
Phase N/A

Powered by AI

Overview

This study aims to evaluate the impact of the dental restorative procedure known as Deep Marginal Elevation (DME) on periodontal health, including gingival and bone status, in patients with deep dental caries. Gingival fluid samples will be collected, and radiographic assessments will be performed to monitor changes in inflammation and bone levels. The findings are expected to provide insights into how DME influences gingival and bone health.

Description

Deep Marginal Elevation (DME) represents a significant advancement in restorative dentistry, providing a promising solution for the management of deep caries lesions, particularly in Class II cavities. The technique involves elevating the deep margin of the cavity to a more accessible level, thereby facilitating placement of a durable restoration while preserving pulp vitality.

Despite increasing adoption in clinical practice, the impact of DME on the periodontal microenvironment-specifically its influence on inflammatory and microbiological markers-remains insufficiently explored.

Inflammatory markers such as Interleukin-1β (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), Matrix Metalloproteinase-8 (MMP-8), Prostaglandin E2 (PGE2), and C-Reactive Protein (CRP) play pivotal roles in the pathogenesis of periodontal disease. Monitoring these biomarkers in gingival crevicular fluid (GCF) provides valuable insights into the inflammatory status of periodontal tissues.

In addition to inflammatory markers, bone level and bone density serve as critical indicators of periodontal health, with alterations often reflecting disease progression. Bitewing radiographs offer a reliable method for assessing these parameters.

This investigation is designed as a longitudinal clinical study to evaluate the effects of DME on GCF microbiological and inflammatory markers, as well as bone level, crestal bone loss, and bone density.

Eligibility

Inclusion Criteria:

  • Patients aged 18-60 years.
  • Diagnosed with Class II dental caries requiring restoration.
  • Presence of a healthy contralateral tooth (control side).
  • Willingness to participate and comply with follow-up visits.

Exclusion Criteria:

  • Systemic diseases (e.g., diabetes, autoimmune disorders).
  • Periodontal disease or active infection.
  • Use of anti-inflammatory medications within the last month.
  • Pregnancy or lactation.

Study details
    Deep Marginal Elevation
    Periodontal Microenvironment
    Microbiological Study
    Clinical Study
    Radiographic Study

NCT07156695

Tanta University

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.