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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTanta University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Deep Marginal Elevation (DME)

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Deep Marginal Elevation (DME)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 month post-intervention.

Secondary outcomes

1

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.

Time frame
1 month post-intervention.
2

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.

Time frame
1 month post-intervention.
3

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.

Time frame
1 month post-intervention.
4

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.

Time frame
1 month post-intervention.

Other outcomes

Sponsors and contacts

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