Evaluation of Periodontal Response on Proximal Surfaces With Deep Margin Elevation in CAD/CAM Restorations of Endodontically Treated Posterior Teeth
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the periodontal response of proximal surfaces with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems. Deep subgingival margins present clinical challenges in terms of isolation, restoration, and long-term periodontal health.
DME is a minimally invasive technique used to relocate subgingival margins coronally to a supragingival level, facilitating adhesive procedures and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear.
In this prospective split-tooth clinical study, proximal surfaces treated with DME will be compared with control surfaces without DME within the same tooth. The primary outcome will be bleeding on probing (BOP), while secondary outcomes will include probing depth and plaque index. Clinical and radiographic evaluations will be performed at baseline and during follow-up.
The results of this study are expected to provide clinical evidence regarding the periodontal impact of DME and support clinical decision-making in the restoration of endodontically treated posterior teeth.
详细描述
This prospective split-tooth controlled clinical study aims to evaluate the periodontal response associated with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems.
Endodontically treated teeth frequently present with extensive structural loss due to caries, previous restorations, or endodontic access cavity preparation, which compromises the structural integrity of the tooth. In such cases, deep subgingival margins are commonly encountered, making isolation, adhesive procedures, and restorative treatment more challenging. Deep margin elevation (DME) is a minimally invasive technique used to relocate subgingival margins coronally to the cemento-enamel junction level using resin composite, facilitating adhesive procedures, digital impression taking, and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear and require further clinical investigation.
A total of 45 restorations will be included in patients aged between 18 and 65 years who present with at least one endodontically treated posterior tooth with extensive coronal destruction. A split-tooth design will be used, where one proximal surface requiring deep margin elevation will be assigned as the test surface (DME), while the opposing proximal surface with supragingival or equigingival margin will serve as the control.
All clinical procedures will be performed at the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University. Before treatment, professional cleaning will be performed using a pumice-water mixture and polishing instruments to remove plaque accumulation. All restorative procedures will be carried out under rubber dam isolation using ×3 magnification dental loupes.
During the DME procedure, isolation will be achieved using a sectional matrix system and wedges. A universal adhesive system (G-Premio Bond, GC, Tokyo, Japan) will be applied following enamel conditioning with 37% phosphoric acid for 10-15 seconds. The subgingival margin will then be elevated to the enamel level using a high-filled injectable composite resin (G-ænial Universal Injectable, GC, Tokyo, Japan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •Presence of at least one endodontically treated posterior tooth (premolar or molar) with extensive coronal structure loss
- •Teeth indicated for indirect CAD/CAM restoration
- •Presence of at least one proximal surface requiring deep margin elevation (subgingival margin)
- •Opposing proximal surface with supragingival or equigingival margin suitable as control
- •Good general health and ability to attend follow-up visits
- •Signed informed consent
排除标准
- •Patients with poor oral hygiene or uncontrolled periodontal disease
- •Presence of active periodontal disease requiring treatment
- •Teeth with mobility greater than Grade I
- •Teeth with periapical pathology or unsuccessful endodontic treatment
- •Patients with systemic diseases affecting periodontal health (e.g., uncontrolled diabetes)
- •Pregnant or lactating women
- •Patients using medications affecting gingival tissues (e.g., immunosuppressants, calcium channel blockers)
- •Heavy smokers
- •Patients unable to comply with follow-up schedule
研究组 & 干预措施
Deep Margin Elevation
Proximal surfaces treated with deep margin elevation (DME) using a resin composite to relocate subgingival margins to a supragingival level prior to CAD/CAM restoration.
干预措施: Deep Margin Elevation (Procedure)
Control (No DME)
Proximal surfaces restored without deep margin elevation, where margins are located at supragingival or equigingival levels.
干预措施: CAD/CAM Restoration Without DME (Procedure)
结局指标
主要结局
未指定
次要结局
- Gingival Index (GI) Scores(Baseline (1 week post-treatment), 6 months, and 12 months)
- Plaque Index (PI) Scores(Baseline (1 week post-treatment), 6 months, and 12 months)
- Clinical Performance of CAD/CAM Endocrowns using FDI Criteria(1 week (Baseline), 6 months, and 12 months post-treatment)
研究者
Büşra Kara Yıldız
Research Assistant,Principal Investigator
Hacettepe University