Mersin University, Faculty of Dentistry
Mersin, 33343, Turkey (Türkiye)
Location contact
Esra Cengiz Yanardag, DDS, PhD
CONTACT
Esra Cengiz Yanardag, DDS, PhD
PRINCIPAL_INVESTIGATOR
Funda Sezer, DDS
CONTACT
Funda Sezer, DDS
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07234266
The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–84 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
3d printed resin restoration with deep margin elevation
DeviceThe teeth are restored with 3D printed permanent resins after deep margin elevation
Primary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Esra Cengiz Yanardag, DDS, PhD
CONTACT
Funda Sezer, DDs
CONTACT
Sponsors and collaborators
Lead sponsor
Mersin University
Other
Registry information
Official study 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
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 18, 2025
- Registry last updated
- Nov 18, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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