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

Tanta University

Status: Enrolling

Conditions: Radiographic Study; Deep Marginal Elevation; Clinical Study; Microbiological Study; Periodontal Microenvironment

Treatments: Procedure: Deep Marginal Elevation (DME)

Study type: Interventional

Funder types: Other

Identifiers

NCT07156695

#R-RD-2-25-3190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Deep Marginal Elevation (DME)

Experimental group

Description:

Participants with Class II dental caries will receive Deep Marginal Elevation (DME) using resin-modified glass ionomer cement (RMGIC) followed by adhesive and nano filled composite restoration.

Treatment:

Procedure: Deep Marginal Elevation (DME)