About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Single group
Treatments tested in this trial
Deep Marginal Elevation (DME)
Procedure/SurgeryDeep 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Changes in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Measurement of cytokines (IL-1β, TNF-α, MMP-8, PGE2, CRP) in GCF samples to assess the inflammatory periodontal response to Deep Marginal Elevation will be recorded at the baseline, immediately post-intervention, and 1 month post-intervention.
Changes in Bone Level
Evaluation of the distance from the cementoenamel junction (CEJ) to the alveolar crest on standardized bitewing radiographs will be recorded at the baseline, immediately post-intervention, and 1 month post-intervention.
Changes in Crestal Bone Loss
Quantification of crestal bone height reduction associated with the intervention using standardized bitewing radiographs will be recorded at the baseline, immediately post-intervention, and 1 month post-intervention.
Changes in Bone Density
Grayscale analysis of alveolar bone density from standardized bitewing radiographs will be recorded at the baseline, immediately post-intervention, and 1 month post-intervention.
Sponsors and contacts
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