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

NCT07156695 | Recruiting

• 1 other identifier: #R-RD-2-25-3190
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes in Gingival Crevicular Fluid (GCF) Microbiological Markers

  Assessment of microbial load in GCF samples to evaluate the microbiological impact of Deep Marginal Elevation will be recorded at the baseline, immediately post-intervention, and 1 month post-intervention.

  1 month post-intervention.

Secondary Outcomes (7)

• Changes in Gingival Crevicular Fluid (GCF) Inflammatory Markers

  1 month post-intervention.

• Changes in Bone Level

  1 month post-intervention.

• Changes in Crestal Bone Loss

  1 month post-intervention.

• Changes in Bone Density

  1 month post-intervention.

• Changes in Gingival Index (GI)

  1 month post-intervention.

Study Arms (1)

Deep Marginal Elevation (DME)

EXPERIMENTAL

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.

Procedure: Deep Marginal Elevation (DME)

Interventions

Deep Marginal Elevation (DME) 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.

Deep Marginal Elevation (DME)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohamed O Elboraey, MD

CONTACT

00201062250015; mohamedomarelboraey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Tanta, University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 5, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)