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临床试验/NCT07234266
NCT07234266尚未招募不适用

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

Mersin University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
试验地点
1
主要终点
Clinical performance and periodontal paremetres

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 3d printed resin restoration with deep margin elevation (Device)

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

干预措施: 3d printed resin restoration with deep margin elevation (Device)

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

干预措施: 3d printed resin restoration with deep margin elevation (Device)

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

干预措施: 3d printed resin restoration with deep margin elevation (Device)

结局指标

主要结局

Clinical performance and periodontal paremetres

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Cengiz Yanardag

Professor

Mersin University

研究点 (1)

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