Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 2:40 PM
Study NCT ID:
NCT07156695
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: