Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Marginal Elevation (DME).
- Who it may be relevant to
- Registry conditions: Deep Marginal Elevation, Periodontal Microenvironment, Microbiological Study, Clinical Study. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
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.
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.
Interventions
- Procedure 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.
Primary outcome measures
- Changes in Gingival Crevicular Fluid (GCF) Microbiological Markers [Time frame: 1 month post-intervention.]
Secondary outcome measures (7)
- Changes in Gingival Crevicular Fluid (GCF) Inflammatory Markers [Time frame: 1 month post-intervention.]
- Changes in Bone Level [Time frame: 1 month post-intervention.]
- Changes in Crestal Bone Loss [Time frame: 1 month post-intervention.]
- Changes in Bone Density [Time frame: 1 month post-intervention.]
- Changes in Gingival Index (GI) [Time frame: 1 month post-intervention.]
- Changes in Bleeding Index (BI) [Time frame: 1 month post-intervention.]
- Changes in Clinical Attachment Loss (CAL) [Time frame: 1 month post-intervention.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07156695 · #R-RD-2-25-3190