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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Marginal Elevation
• Intervention / Treatment: Device: 3d printed resin restoration with deep margin elevation

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Cengiz Yanardag, DDS, PhD; Phone Number: +905052443472; Email: esracengiz@mersin.edu.tr
• Study Contact Backup: Name: Funda Sezer, DDS; Phone Number: 0905382140978; Email: szrrfunda@gmail.com

Study Locations

• Turkey (Türkiye)
  • Mersin
    • Mersin, Mersin, Turkey (Türkiye), 33343
      • Mersin University, Faculty of Dentistry
      • Contact: Esra Cengiz Yanardag, DDS, PhD; Phone Number: 0905052443472; Email: esracengiz@mersin.edu.tr
      • Principal Investigator: Esra Cengiz Yanardag, DDS, PhD
      • Contact: Funda Sezer, DDS; Phone Number: 0905382140978; Email: szrrfunda@gmail.com
      • Principal Investigator: Funda Sezer, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 3d printed resin restoration with deep margin elevation; The teeth are restored with 3D printed permanent resins after deep margin elevation
Active Comparator: 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	Device: 3d printed resin restoration with deep margin elevation; The teeth are restored with 3D printed permanent resins after deep margin elevation
Active Comparator: 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	Device: 3d printed resin restoration with deep margin elevation; The teeth are restored with 3D printed permanent resins after deep margin elevation
Active Comparator: 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	Device: 3d printed resin restoration with deep margin elevation; The teeth are restored with 3D printed permanent resins after deep margin elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: composite resin; indirect restoration; deep margin elevation; additively manufactured
• Other Study ID Numbers: 2025/909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No