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

NCT07234266 | Not Yet Recruiting DMC

• 1 other identifier: 2025/909
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

deep margin elevation; indirect restoration; additively manufactured; composite resin

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 6 months, 12 months

Study Arms (4)

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.

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

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

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

Device: 3d printed resin restoration with deep margin elevation

Interventions

3d printed resin restoration with deep margin elevation DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University, Faculty of Dentistry

Mersin, Mersin, 33343, Turkey (Türkiye)

Location

Central Study Contacts

Esra Cengiz Yanardag, DDS, PhD

CONTACT

+905052443472; esracengiz@mersin.edu.tr

Funda Sezer, DDs

CONTACT

0905382140978; szrrfunda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)