Actively Recruiting
Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
Led by Tanta University · Updated on 2025-09-05
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of the dental procedure called Deep Marginal Elevation (DME) on gum and bone health in patients with deep dental cavities, specifically Class II caries. This study aims to understand how DME influences inflammatory and microbiological markers in the periodontal environment, including the status of gingival tissues and bone levels. The research focuses on markers found in gingival fluid and bone changes seen through radiographic imaging to shed light on DME's impact. The treatment involves elevating the deep margin of the cavity using resin-modified glass ionomer cement, followed by adhesive bonding and placement of a nanofilled composite restoration. This method helps improve access to the restoration margin and supports better sealing and plaque control. Participants will receive this single DME procedure as part of the study. During the study, gingival fluid samples will be collected to measure microbiological and inflammatory markers such as IL-1b2, TNF-b1, MMP-8, PGE2, and CRP. Radiographs will assess bone level, bone density, and crestal bone loss. Clinical evaluations including Gingival Index, Bleeding Index, and Clinical Attachment Loss will be performed. These assessments will take place one month after the intervention to monitor changes and safety. The total participation spans this follow-up period.
CONDITIONS
Brief Title
Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 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
You will not qualify if you...
- Presence of systemic diseases such as diabetes or autoimmune disorders
- Having periodontal disease or active infection
- Use of anti-inflammatory medications within the last month
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive Deep Marginal Elevation (DME) to elevate the deep margin of Class II cavities followed by restoration with resin-modified glass ionomer cement and nanofilled composite resin.
1 treatment visit (in-person)
Duration - 1 month post-intervention
Participants are monitored for changes in gingival crevicular fluid microbiological and inflammatory markers, bone level, crestal bone loss, bone density, and periodontal health indicators.
1 follow-up visit (in-person) approximately 1 month after treatment
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
M
Mohamed O Elboraey, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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