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Periodontal HealthDME-PERIONCT07661719

Deep Margin Elevation in Endodontically Treated Posterior Teeth

A study testing Deep Margin Elevation and CAD/CAM Restoration Without DME in people with Periodontal Health and Endodontically Treated Teeth, run by Hacettepe University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to evaluate the periodontal response of proximal surfaces with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems. Deep subgingival margins present clinical challenges in terms of isolation, restoration, and long-term periodontal health. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Deep Margin Elevation and CAD/CAM Restoration Without DME
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Mar 2026to 24 Apr 2027
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18 and 65 years
  • Presence of at least one endodontically treated posterior tooth (premolar or molar) with extensive coronal structure loss
  • Teeth indicated for indirect CAD/CAM restoration
  • Presence of at least one proximal surface requiring deep margin elevation (subgingival margin)
  • Opposing proximal surface with supragingival or equigingival margin suitable as control
  • Good general health and ability to attend follow-up visits
  • Signed informed consent

Who cannot join

  • Patients with poor oral hygiene or uncontrolled periodontal disease
  • Presence of active periodontal disease requiring treatment
  • Teeth with mobility greater than Grade I
  • Teeth with periapical pathology or unsuccessful endodontic treatment
  • Patients with systemic diseases affecting periodontal health (e.g., uncontrolled diabetes)
  • Pregnant or lactating women
Show all 9Show fewer
  • Patients using medications affecting gingival tissues (e.g., immunosuppressants, calcium channel blockers)
  • Heavy smokers
  • Patients unable to comply with follow-up schedule

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Periodontal Response on Proximal Surfaces With Deep Margin Elevation in CAD/CAM Restorations of Endodontically Treated Posterior Teeth

This study aims to evaluate the periodontal response of proximal surfaces with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems. Deep subgingival margins present clinical challenges in terms of isolation, restoration, and long-term periodontal health.

DME is a minimally invasive technique used to relocate subgingival margins coronally to a supragingival level, facilitating adhesive procedures and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear.

Read more

In this prospective split-tooth clinical study, proximal surfaces treated with DME will be compared with control surfaces without DME within the same tooth. The primary outcome will be bleeding on probing (BOP), while secondary outcomes will include probing depth and plaque index. Clinical and radiographic evaluations will be performed at baseline and during follow-up.

The results of this study are expected to provide clinical evidence regarding the periodontal impact of DME and support clinical decision-making in the restoration of endodontically treated posterior teeth.

Read the detailed description

This prospective split-tooth controlled clinical study aims to evaluate the periodontal response associated with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems.

Endodontically treated teeth frequently present with extensive structural loss due to caries, previous restorations, or endodontic access cavity preparation, which compromises the structural integrity of the tooth. In such cases, deep subgingival margins are commonly encountered, making isolation, adhesive procedures, and restorative treatment more challenging. Deep margin elevation (DME) is a minimally invasive technique used to relocate subgingival margins coronally to the cemento-enamel junction level using resin composite, facilitating adhesive procedures, digital impression taking, and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear and require further clinical investigation.

A total of 45 restorations will be included in patients aged between 18 and 65 years who present with at least one endodontically treated posterior tooth with extensive coronal destruction. A split-tooth design will be used, where one proximal surface requiring deep margin elevation will be assigned as the test surface (DME), while the opposing proximal surface with supragingival or equigingival margin will serve as the control.

All clinical procedures will be performed at the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University. Before treatment, professional cleaning will be performed using a pumice-water mixture and polishing instruments to remove plaque accumulation. All restorative procedures will be carried out under rubber dam isolation using ×3 magnification dental loupes.

During the DME procedure, isolation will be achieved using a sectional matrix system and wedges. A universal adhesive system (G-Premio Bond, GC, Tokyo, Japan) will be applied following enamel conditioning with 37% phosphoric acid for 10-15 seconds. The subgingival margin will then be elevated to the enamel level using a high-filled injectable composite resin (G-ænial Universal Injectable, GC, Tokyo, Japan).

All restorations will be fabricated using a chairside CAD/CAM system (CEREC Omnicam, Dentsply Sirona, Bensheim, Germany) and milled from a resin nanoceramic hybrid block (Cerasmart 270, GC, Tokyo, Japan) according to the manufacturer's instructions.

The internal surface of the restoration will be sandblasted with 50 µm aluminum oxide, cleaned with alcohol, and treated with G-CEM ONE Adhesive Primer (GC, Tokyo, Japan). The tooth surface will be conditioned with 37% phosphoric acid, followed by the application of G-Premio Bond. Restorations will be luted using a self-adhesive resin cement (G-CEM ONE, GC, Tokyo, Japan). Excess cement will be removed after short light exposure, and final polymerization will be performed using a high-intensity LED curing unit (Bluephase N, Ivoclar Vivadent), with 10 seconds of curing per surface.

Finishing and polishing procedures will be completed using fine diamond burs, aluminum oxide-coated polishing discs, and polishing systems. Occlusion will be checked and adjusted when necessary.

Periodontal parameters will be recorded at baseline (T0) and at follow-up visits at 1 week, 6 months, and 12 months. The primary outcome measure will be bleeding on probing (BOP), assessed at six sites per tooth, and the presence of bleeding at any site will be recorded as positive. Secondary outcome measures will include probing pocket depth (PPD) measured in millimeters and plaque index (PI). Gingival index (GI) will also be recorded as an additional parameter.

Restorations will be evaluated according to FDI criteria by two calibrated clinicians who are blinded to the intervention. Functional, biological, esthetic, and patient-related parameters will be assessed. Patient satisfaction will be evaluated using a 5-point Likert scale including general, esthetic, and functional satisfaction.

Sample size calculation was performed using G*Power 3.1 software based on McNemar test assumptions for paired data (α=0.05, power=80%). Based on estimated discordant proportions (p10=0.27 and p01=0.03), the minimum required sample size was calculated as 40 teeth. Considering a potential 10% dropout rate, a total of 45 restorations will be included.

Statistical analysis will be performed using SPSS software. Differences in BOP between test and control surfaces will be analyzed using the McNemar test. PPD and PI values will be analyzed using the Wilcoxon signed-rank test. Changes over time will also be evaluated using paired statistical methods. A significance level of p<0.05 will be considered statistically significant.

This study is expected to provide clinically relevant evidence regarding the periodontal effects of deep margin elevation and contribute to evidence-based decision-making in the restorative management of endodontically treated posterior teeth.

Being tested
Deep Margin Elevation, CAD/CAM Restoration Without DME
Keywords
Deep Margin Elevation, CAD/CAM, Endocrown, Periodontal Response, Split-Mouth Study, DME
Medical subject headings
Tooth, Nonvital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Margin ElevationProcedure or surgery

    Deep margin elevation (DME) is performed by relocating subgingival proximal margins coronally using a high-filled injectable composite resin following adhesive procedures, prior to CAD/CAM restoration placement.

  • CAD/CAM Restoration Without DMEProcedure or surgery

    Restorative treatment is performed without deep margin elevation, where proximal margins remain at supragingival or equigingival levels and are restored using CAD/CAM systems.

Study groups in NCT07661719
Study groupRoleWhat they receive
Deep Margin ElevationExperimentalProximal surfaces treated with deep margin elevation (DME) using a resin composite to relocate subgingival margins to a supragingival level prior to CAD/CAM restoration.
Receives: Procedure: Deep Margin Elevation
Control (No DME)Active comparatorProximal surfaces restored without deep margin elevation, where margins are located at supragingival or equigingival levels.
Receives: Procedure: CAD/CAM Restoration Without DME

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding on Probing (BOP) Positive Surface Proportion

    Gingival inflammation will be assessed by measuring Bleeding on Probing (BOP) using a periodontal probe at six sites per tooth (mesio-buccal, mesio-lingual, mid-buccal, mid-lingual, disto-buccal, and disto-lingual) . The presence of bleeding at any site within the proximal area will be recorded as positive . The proportion of BOP-positive surfaces will be compared between the deep margin elevation (DME) surfaces (experimental group) and the non-DME supragingival surfaces (control group) on the same tooth.

    Measured: Baseline (1 week post-treatment), 6 months, and 12 months

Secondary outcomes (4)
  1. Changes in Periodontal Pocket Depth (PPD)

    Periodontal pocket depth (PPD) will be measured in millimeters using a periodontal probe at the same six sites per tooth (mesio-buccal, mesio-lingual, mid-buccal, mid-lingual, disto-buccal, and disto-lingual) . The distance from the gingival margin to the bottom of the periodontal pocket will be recorded to evaluate dimensional changes over time and compare DME vs. control surfaces.

    Measured: Baseline (1 week post-treatment), 6 months, and 12 months

  2. Plaque Index (PI) Scores

    Gingival plaque accumulation will be evaluated at the evaluated proximal surfaces using the Silness and Löe Plaque Index scoring system.This ordinal index scores plaque retention specifically at the marginal area to assess oral hygiene correlation with the restorations.

    Plaque Index (PI) Scores: Plaque Index is assessed using the Silness and Löe Plaque Index, with scores ranging from 0 to 3, where 0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent tooth surface, 2 = moderate accumulation of plaque, and 3 = abundant plaque accumulation. Higher scores indicate worse oral hygiene.

    Measured: Baseline (1 week post-treatment), 6 months, and 12 months

  3. Gingival Index (GI) Scores

    Clinical evaluation of gingival health will be performed using the Löe and Silness Gingival Index[cite: 1]. The assessment will be conducted at both the deep margin elevation (DME) surface and the non-DME proximal surface using a periodontal probe to grade tissue condition and inflammation severity.

    Gingival Index (GI) Scores: Gingival health is assessed using the Löe and Silness Gingival Index, with scores ranging from 0 to 3, where 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation with bleeding on probing, and 3 = severe inflammation with spontaneous bleeding. Higher scores indicate worse gingival health.

    Measured: Baseline (1 week post-treatment), 6 months, and 12 months

  4. Clinical Performance of CAD/CAM Endocrowns using FDI Criteria

    The clinical quality and success of the Cerasmart 270 hybrid ceramic endocrown restorations will be evaluated by two calibrated independent examiners using the World Dental Federation (FDI) criteria[cite: 1]. The assessment covers functional criteria (retention, fracture, marginal adaptation, proximal contact), biological criteria (secondary caries, tooth integrity), and aesthetic criteria (color match, surface gloss) using a 5-point scoring system.

    Clinical Performance of CAD/CAM Endocrowns using FDI Criteria: Clinical performance is assessed using the FDI World Dental Federation Clinical Criteria for the Evaluation of Direct and Indirect Restorations. Each criterion is scored on a 5-point scale (1-5), where 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory but repairable, and 5 = clinically poor (replacement required). Higher scores indicate worse clinical performance of the restoration.

    Measured: 1 week (Baseline), 6 months, and 12 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start24 Mar 2026
  3. Primary completion24 Oct 2026 (estimated)
  4. Study completion24 Apr 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
This study uses a split-tooth design, where different proximal surfaces of the same tooth receive different interventions. One proximal surface is treated with deep margin elevation (DME), while the opposing surface serves as the control without DME. This design allows direct intra-tooth comparison of periodontal outcomes under identical patient-related conditions.
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661719
Sponsor's protocol ID
KA-25049
Acronym
DME-PERIO
Status last verified
Jun 2026
First submitted
20 Apr 2026
Last updated
2 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Deep Margin Elevation and CAD/CAM Restoration Without DME in people with Periodontal Health and Endodontically Treated Teeth, run by Hacettepe University at 1 site in Turkey (Türkiye).

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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. 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 Turkey (Türkiye). 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding on Probing (BOP) Positive Surface Proportion (time frame: Baseline (1 week post-treatment), 6 months, and 12 months). 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 2 Jul 2026.

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