Deep Marginal ElevationNCT07234266
The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation
A study testing 3d printed resin restoration with deep margin elevation in people with Deep Marginal Elevation, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
In dentistry, particularly in posterior teeth with extensive caries or old restorations, the extension of restoration margins below the gingival level presents a significant clinical challenge. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Deep Marginal Elevation
- What is being tested?
- 3d printed resin restoration with deep margin elevation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Dec 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who apply to Mersin University Faculty of Dentistry between 01.12.2025 and 01.03.2026 for restorative treatment of their teeth
- Patients aged between 18 and 84 years
- Patients without parafunctional habits (such as bruxism, clenching, or foreign object chewing)
- Vital or non-vital molar and premolar teeth with a clinical indication for inlay/onlay restoration
- Teeth with deep cavities and margins located at or slightly below the gingival level
- Defects limited to the occlusal surface and one proximal surface
Show all 10Show fewer
- Occlusal defects extending beyond one-third of the distance between fissure and cusp tip, including at least one cusp
- Posterior teeth with an indication for deep margin elevation without violation of the biologic width
- Teeth with opposing natural teeth or fixed prosthetic restorations
- Teeth with the presence of adjacent proximal contacts
Who cannot join
- Teeth with fractures or cracks
- Patients with temporomandibular joint disorders
- Patients with malocclusion, bruxism, or parafunctional habits
- Posterior teeth without opposing natural teeth or fixed prosthetic restorations
- Posterior teeth without adjacent proximal contacts
- Patients with a history of allergy to the components of the restorative materials used
- Patients with severe gingival enlargement, gingival recession, or active periodontal disease
- Teeth requiring deep margin elevation that present with non-physiological mobility, fistula, or periapical lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University, Faculty of Dentistry
Mersin, Mersin, 33343
Esra Cengiz Yanardag, DDS, PhD, 0905052443472, esracengiz@mersin.edu.tr
Funda Sezer, DDS, 0905382140978, szrrfunda@gmail.com
About this study
Official title: Effect of Restorative Material Selection on Periodontal and Clinical Success in Teeth Restored With Indirect Restorations Fabricated by Additive Manufacturing After Deep Margin Elevation: A One-Year Clinical Follow-Up Study
In dentistry, particularly in posterior teeth with extensive caries or old restorations, the extension of restoration margins below the gingival level presents a significant clinical challenge. In such cases, restorative procedures become more complicated, periodontal health may be adversely affected, and long-term tissue loss can occur. To overcome this problem, the "Deep Margin Elevation" technique has been developed. This approach aims to raise subgingival margins caused by caries or fractures above the gingival level, thereby providing a healthier and more favorable foundation for successful treatment.
In this study, two different materials will be used for deep margin elevation, followed by restoration of the teeth with indirect restorations fabricated using additive manufacturing technology, which has become increasingly popular in recent years. Two different additive manufacturing resins will also be applied in the restorative phase. The teeth treated with deep margin elevation and indirect restorations will be evaluated at baseline, 6 months, and 12 months according to the FDI criteria, as well as periodontal parameters due to the involvement of the gingival region.
This study aims to highlight the importance of material selection in restorative treatment planning and to scientifically demonstrate the impact of the applied technique on surrounding tissues. Furthermore, it will provide an evidence-based perspective on how adopting a tissue-friendly approach during restorative procedures may contribute to favorable long-term outcomes.
- Conditions
- Deep Marginal Elevation
- Being tested
- 3d printed resin restoration with deep margin elevation
- Keywords
- deep margin elevation, indirect restoration, additively manufactured, composite resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed resin restoration with deep margin elevationDevice
The teeth are restored with 3D printed permanent resins after deep margin elevation
| Study group | Role | What they receive |
|---|---|---|
| Saremco print resin- 3M Filtek One Bulk Fill Restorative | Active comparator | The teeth is restored with Saremco print resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative. Receives: Device: 3d printed resin restoration with deep margin elevation |
| Saremco print resin- GC Gaeanial Universal Injectable | Active comparator | The teeth is restored with Saremco print resin after deep margin elevation is performed with GC Gaeanial Universal Injectable Receives: Device: 3d printed resin restoration with deep margin elevation |
| Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative | Active comparator | The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative Receives: Device: 3d printed resin restoration with deep margin elevation |
| Varseosmile TriniQ resin- GC Gaeanial Universal Injectable | Active comparator | The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with GC Gaeanial Universal Injectable Receives: Device: 3d printed resin restoration with deep margin elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance and periodontal paremetres
The clinical evaluation of restorations bonded to teeth will be performed using World Dental Federation (FDI) criteria in addition to periodontal parameters. Regarding FDI criteria, each property is typically scored on a 1 to 5 scale: 1- Clinically excellent, 2- Clinically good, 3- Clinically sufficient, 4- Clinically insufficient, 5- Clinically poor Regarding gingival index, 0-1: Clinically acceptable, 1-2: Clinically unacceptable Regarding plaque index, 0-1 clinically acceptable, 2 borderline, 3 clinically unacceptable In terms of probing pocket depth, ≤3 mm clinically acceptable, 4-5 mm borderline ≥6 mm s clinically unacceptable
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 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.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Cengiz Yanardag, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234266
- Sponsor's protocol ID
- 2025/909
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Restorative Material Selection on Periodontal and Clinical Success in Teeth Restored With Indirect Restorations Fabricated by Additive Manufacturing After Deep Margin Elevation: A One-Year Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT07234266
- Acronym / sponsor ID
- 2025/909
- Conditions
- Deep Marginal Elevation
- Keywords
- deep margin elevation, indirect restoration, additively manufactured, composite resin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 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.
In dentistry, particularly in posterior teeth with extensive caries or old restorations, the extension of restoration margins below the gingival level presents a significant clinical challenge. In such cases, restorative procedures become more complicated, periodontal health may be adversely affected, and long-term tissue loss can occur. To overcome this problem, the "Deep Margin Elevation" technique has been developed. This approach aims to raise subgingival margins caused by caries or fractures above the gingival level, thereby providing a healthier and more favorable foundation for successful treatment.
In this study, two different materials will be used for deep margin elevation, followed by restoration of the teeth with indirect restorations fabricated using additive manufacturing technology, which has become increasingly popular in recent years. Two different additive manufacturing resins will also be applied in the restorative phase. The teeth treated with deep margin elevation and indirect restorations will be evaluated at baseline, 6 months, and 12 months according to the FDI criteria, as well as periodontal parameters due to the involvement of the gingival region.
This study aims to highlight the importance of material selection in restorative treatment planning and to scientifically demonstrate the impact of the applied technique on surrounding tissues. Furthermore, it will provide an evidence-based perspective on how adopting a tissue-friendly approach during restorative procedures may contribute to favorable long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saremco print resin- 3M Filtek One Bulk Fill Restorative | Active comparator | Device: 3d printed resin restoration with deep margin elevationThe teeth is restored with Saremco print resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative. |
| Saremco print resin- GC Gaeanial Universal Injectable | Active comparator | Device: 3d printed resin restoration with deep margin elevationThe teeth is restored with Saremco print resin after deep margin elevation is performed with GC Gaeanial Universal Injectable |
| Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative | Active comparator | Device: 3d printed resin restoration with deep margin elevationThe teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative |
| Varseosmile TriniQ resin- GC Gaeanial Universal Injectable | Active comparator | Device: 3d printed resin restoration with deep margin elevationThe teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with GC Gaeanial Universal Injectable |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who apply to Mersin University Faculty of Dentistry between 01.12.2025 and 01.03.2026 for restorative treatment of their teeth
- Patients aged between 18 and 84 years
- Patients without parafunctional habits (such as bruxism, clenching, or foreign object chewing)
- Vital or non-vital molar and premolar teeth with a clinical indication for inlay/onlay restoration
- Teeth with deep cavities and margins located at or slightly below the gingival level
Key exclusion criteria (8 listed)
- Teeth with fractures or cracks
- Patients with temporomandibular joint disorders
- Patients with malocclusion, bruxism, or parafunctional habits
- Posterior teeth without opposing natural teeth or fixed prosthetic restorations
- Posterior teeth without adjacent proximal contacts
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 |
|---|---|---|
| 3d printed resin restoration with deep margin elevationThe teeth are restored with 3D printed permanent resins after deep margin elevation | Device | Saremco print resin- 3M Filtek One Bulk Fill Restorative, Saremco print resin- GC Gaeanial Universal Injectable, Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative, Varseosmile TriniQ resin- GC Gaeanial Universal Injectable |
Primary outcome
Clinical performance and periodontal paremetres
Time frame: Baseline, 6 months, 12 months
The clinical evaluation of restorations bonded to teeth will be performed using World Dental Federation (FDI) criteria in addition to periodontal parameters. Regarding FDI criteria, each property is typically scored on a 1 to 5 scale: 1- Clinically excellent, 2- Clinically good, 3- Clinically sufficient, 4- Clinically insufficient, 5- Clinically poor Regarding gingival index, 0-1: Clinically acceptable, 1-2: Clinically unacceptable Regarding plaque index, 0-1 clinically acceptable, 2 borderline, 3 clinically unacceptable In terms of probing pocket depth, ≤3 mm clinically acceptable, 4-5 mm borderline ≥6 mm s clinically unacceptable
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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 3d printed resin restoration with deep margin elevation in people with Deep Marginal Elevation, run by Mersin 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 10 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Nov 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 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?
Contact Esra Cengiz Yanardag, DDS, PhD (+905052443472, esracengiz@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance and periodontal paremetres (time frame: Baseline, 6 months, 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 18 Nov 2025.