The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation

NCT ID: NCT07234266

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Marginal Elevation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Saremco print resin- 3M Filtek One Bulk Fill Restorative

The teeth is restored with Saremco print resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative.

Group Type ACTIVE_COMPARATOR

3d printed resin restoration with deep margin elevation

Intervention Type DEVICE

The teeth are restored with 3D printed permanent resins after deep margin elevation

Saremco print resin- GC Gaeanial Universal Injectable

The teeth is restored with Saremco print resin after deep margin elevation is performed with GC Gaeanial Universal Injectable

Group Type ACTIVE_COMPARATOR

3d printed resin restoration with deep margin elevation

Intervention Type DEVICE

The teeth are restored with 3D printed permanent resins after deep margin elevation

Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative

The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative

Group Type ACTIVE_COMPARATOR

3d printed resin restoration with deep margin elevation

Intervention Type DEVICE

The teeth are restored with 3D printed permanent resins after deep margin elevation

Varseosmile TriniQ resin- GC Gaeanial Universal Injectable

The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with GC Gaeanial Universal Injectable

Group Type ACTIVE_COMPARATOR

3d printed resin restoration with deep margin elevation

Intervention Type DEVICE

The teeth are restored with 3D printed permanent resins after deep margin elevation

Interventions

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3d printed resin restoration with deep margin elevation

The teeth are restored with 3D printed permanent resins after deep margin elevation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Esra Cengiz Yanardag

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mersin University, Faculty of Dentistry

Mersin, Mersin, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Esra Cengiz Yanardag, DDS, PhD

Role: CONTACT

+905052443472

Funda Sezer, DDs

Role: CONTACT

0905382140978

Facility Contacts

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Esra Cengiz Yanardag, DDS, PhD

Role: primary

0905052443472

Funda Sezer, DDS

Role: backup

0905382140978

Other Identifiers

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2025/909

Identifier Type: -

Identifier Source: org_study_id

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