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Clinical Trials in Egypt / NCT07156695
Recruiting Not applicable

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

NCT07156695 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Not applicable
Started
2025-08-01
Last updated
2025-09-05

Condition(s) studied

Deep Marginal ElevationPeriodontal MicroenvironmentMicrobiological StudyClinical StudyRadiographic Study

Investigational drug(s) / intervention(s)

Deep Marginal Elevation (DME)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Changes in Gingival Crevicular Fluid (GCF) Microbiological Markers — 1 month post-intervention.
    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.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta El-Gharbia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07156695 on ClinicalTrials.gov ↗ ← All trials in Egypt