Deep Marginal ElevationNCT07156695
Deep Marginal Elevation and the Periodontal Microenvironment ( DME-PM )
A study testing Deep Marginal Elevation (DME) in people with Deep Marginal Elevation and Periodontal Microenvironment, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Deep Marginal Elevation, Periodontal Microenvironment, Microbiological Study
- What is being tested?
- Deep Marginal Elevation (DME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohamed O Elboraey, MD, 0021062250015, mohamedomarelboraey@gmail.com
Laila T Kashkosh, MD
About this study
Official title: Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
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.
Read the 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.
- Conditions
- Deep Marginal Elevation, Periodontal Microenvironment, Microbiological Study, Clinical Study, Radiographic Study
- Being tested
- Deep Marginal Elevation (DME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Marginal Elevation (DME)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Marginal Elevation (DME) | Experimental | Participants with Class II dental caries will receive Deep Marginal Elevation (DME) using resin-modified glass ionomer cement (RMGIC) followed by adhesive and nano filled composite restoration. Receives: Procedure: Deep Marginal Elevation (DME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-intervention.
Secondary outcomes (7)
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.
Measured: 1 month post-intervention.
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.
Measured: 1 month post-intervention.
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.
Measured: 1 month post-intervention.
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.
Measured: 1 month post-intervention.
Changes in Gingival Index (GI)
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)
- = Mild inflammation (slight color change, slight edema, no bleeding on probing)
- = Moderate inflammation (redness, edema, glazing, bleeding on probing)
- = Severe inflammation (marked redness and edema, ulceration, spontaneous bleeding) Direction of Scoring: Higher scores indicate worse gingival inflammation.
Measured: 1 month post-intervention.
Changes in Bleeding Index (BI)
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.
Measured: 1 month post-intervention.
Changes in Clinical Attachment Loss (CAL)
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.
Measured: 1 month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Marginal ElevationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar Elboraey Elbal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156695
- Sponsor's protocol ID
- #R-RD-2-25-3190
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Marginal Elevation and Its Impact on Periodontal Microenvironment: Microbiological, Clinical, and Radiographic Study
- ClinicalTrials.gov ID
- NCT07156695
- Acronym / sponsor ID
- #R-RD-2-25-3190
- Conditions
- Deep Marginal Elevation, Periodontal Microenvironment, Microbiological Study, Clinical Study, Radiographic Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Marginal Elevation (DME) | Experimental | Procedure: Deep Marginal Elevation (DME)Participants with Class II dental caries will receive Deep Marginal Elevation (DME) using resin-modified glass ionomer cement (RMGIC) followed by adhesive and nano filled composite restoration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Systemic diseases (e.g., diabetes, autoimmune disorders).
- Periodontal disease or active infection.
- Use of anti-inflammatory medications within the last month.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Marginal Elevation (DME)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. | Procedure or surgery | Deep Marginal Elevation (DME) |
Primary outcome
Changes in Gingival Crevicular Fluid (GCF) Microbiological Markers
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.
7 secondary outcomes
Changes in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Time frame: 1 month post-intervention.
Changes in Bone Level
Time frame: 1 month post-intervention.
Changes in Crestal Bone Loss
Time frame: 1 month post-intervention.
Changes in Bone Density
Time frame: 1 month post-intervention.
Changes in Gingival Index (GI)
Time frame: 1 month post-intervention.
Changes in Bleeding Index (BI)
Time frame: 1 month post-intervention.
Changes in Clinical Attachment Loss (CAL)
Time frame: 1 month post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Deep Marginal Elevation
Active, not recruiting
Deep Margin Elevation in Endodontically Treated Posterior Teeth
Periodontal Health, Endodontically Treated Teeth
Not yet recruiting
The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues
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The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation
Deep Marginal Elevation
Recruiting
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
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Not yet recruiting
Effect of Different Base Materials on Ginigiva During Gingival Margin Elevation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Marginal Elevation (DME) in people with Deep Marginal Elevation and Periodontal Microenvironment, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed O Elboraey, MD (00201062250015, mohamedomarelboraey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gingival Crevicular Fluid (GCF) Microbiological Markers (time frame: 1 month post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.