Deep Marginal Elevation: effects on gum and bone health
Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
This will test if raising the deep margin of a filling (DME) changes gum inflammation and nearby bone levels in adults with deep back-tooth cavities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07156695 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal clinical study of adults needing Class II restorations in which Deep Marginal Elevation (DME) will be performed and patients followed over time. Gingival crevicular fluid will be collected to measure inflammatory markers (e.g., IL-1β, TNF-α, MMP-8, PGE2, CRP) and microbiological profiles. Bitewing radiographs will be used to monitor crestal bone level and bone density changes, using the healthy contralateral tooth as an internal control. Participants with systemic disease, active periodontal infection, recent anti-inflammatory use, pregnancy, or lactation are excluded and follow-up visits are required to track outcomes.
Who should consider this trial
Good fit: Adults aged 18–60 with a Class II deep carious lesion requiring restoration, a healthy contralateral tooth, and willingness to attend follow-up visits are ideal candidates.
Not a fit: Patients with active periodontal disease, systemic conditions such as diabetes, recent anti-inflammatory medication use, pregnancy or lactation, or those without a healthy opposite tooth are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could show that DME preserves gum and bone health while allowing durable restorations, potentially reducing the need for more invasive treatments.
How similar studies have performed: While DME is increasingly used in restorative practice, studies specifically linking DME to changes in periodontal inflammatory or microbiological markers are limited and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Systemic diseases (e.g., diabetes, autoimmune disorders). * Periodontal disease or active infection. * Use of anti-inflammatory medications within the last month. * Pregnancy or lactation.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed O Elboraey, MD
- Email: mohamedomarelboraey@gmail.com
- Phone: 00201062250015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.