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

NCT ID: NCT07156695

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-01-01

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deep Marginal Elevation (DME)

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.

Group Type: EXPERIMENTAL

Deep Marginal Elevation (DME)

Intervention Type: PROCEDURE

Deep Marginal Elevation (DME) is performed by elevating the deep margin of Class II cavities using resin-modified glass ionomer cement (RMGIC), followed by adhesive bonding and placement of a nanofilled composite resin restoration. This procedure improves accessibility of the restorative margin, enhances marginal sealing, and facilitates plaque control.

Interventions

Deep Marginal Elevation (DME)

Deep Marginal Elevation (DME) is performed by elevating the deep margin of Class II cavities using resin-modified glass ionomer cement (RMGIC), followed by adhesive bonding and placement of a nanofilled composite resin restoration. This procedure improves accessibility of the restorative margin, enhances marginal sealing, and facilitates plaque control.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Omar Elboraey Elbal

Assistant Professor of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Tanta, University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed O Elboraey, MD

Role: CONTACT

mohamedomarelboraey@gmail.com

00201062250015

Facility Contacts

Mohamed O Elboraey, MD

Role: primary

mohamedomarelboraey@gmail.com

0021062250015

Other Identifiers

#R-RD-2-25-3190

Identifier Type: -

Identifier Source: org_study_id