NCT Number: NCT07156695
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Tanta, El-Gharbia, 31527, Egypt
Location status: Recruiting
Laila T Kashkosh, MD
PRINCIPAL_INVESTIGATOR
Mohamed O Elboraey, MD
CONTACT
Mohammed A Abd El Ghany, MD
PRINCIPAL_INVESTIGATOR
Mostafa I Fayad, MD
PRINCIPAL_INVESTIGATOR
Sherouk M Gamal, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 1 month post-intervention.
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.
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.
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.
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.
Evaluation of gingival inflammation severity will be performed using the Gingival Index (GI) . This index scores gingival tissues based on color, consistency, and bleeding on probing.
Scale Details:
Range: 0 to 3
0 = Normal gingiva (no inflammation)
Time frame: 1 month post-intervention.
Assessment of gingival bleeding tendency on probing will be performed using the Bleeding Index (BI). This index evaluates the presence or absence of bleeding as an indicator of gingival inflammation.
Scale Details:
Range: 0 to 1
0 = No bleeding on probing
1 = Bleeding on probing present Direction of Scoring: Higher scores indicate worse gingival inflammation.
Time frame: 1 month post-intervention.
Periodontal attachment level will be assessed using a manual periodontal probe to measure the distance (in millimeters) from the cementoenamel junction (CEJ) to the base of the gingival sulcus/pocket. Measurements will be taken at baseline, immediately post-intervention, and at 1-month follow-up to evaluate periodontal tissue stability after Deep Marginal Elevation (DME).
Scale/Units:
Measurement tool: Periodontal probe (UNC-15)
Range: 0 mm to 15 mm (probe scale)
Interpretation:
Lower clinical Attachment Loss (CAL) values = better periodontal attachment and stability
Higher CAL values = greater tissue destruction and worse periodontal health
Direction of Scoring: Higher CAL values indicate worse periodontal outcome.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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