Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score
研究概览
简要总结
This study evaluates the clinical performance, marginal integrity, surface wear, color stability, and postoperative sensitivity of graphene-reinforced CAD/CAM indirect restorations (inlays, onlays, overlays) in molars affected by moderate to severe Molar-Incisor Hypomineralization (MIH) in adolescents. A total of 30 patients aged 10-16 years will receive minimally invasive indirect restorations fabricated from a nano-reinforced graphene polymer (G-CAM®). Clinical outcomes will be assessed using FDI criteria, VAS sensitivity scores, patient satisfaction, and digital 3D scans over a 12-month follow-up. The study aims to determine clinical acceptability and safety compared with historical outcomes reported for composite and lithium-disilicate indirect restorations.
详细描述
This is a prospective, single-arm, monocentric clinical trial designed to assess the functional performance, marginal adaptation, wear behavior, postoperative sensitivity, and structural preservation of graphene-reinforced CAD/CAM restorations placed on MIH-affected molars in adolescents aged 10-16 years. MIH lesions present compromised enamel quality with increased porosity, susceptibility to post-eruptive breakdown, and frequent hypersensitivity, making conventional restorative approaches less predictable.
Minimally invasive preparations will be performed followed by adhesive placement of graphene-reinforced CAD/CAM indirect restorations fabricated through a fully digital workflow (intraoral scanning, CAD design, CAM milling). Evaluations will be performed at baseline, 48 h, 1, 3, 6, and 12 months. Primary variables include global and domain-specific FDI clinical scores (marginal integrity, surface roughness, color stability, fractures/chipping, proximal contact, occlusion/function, soft tissue response) and postoperative sensitivity measured using a Visual Analog Scale (VAS). Secondary outcomes include patient satisfaction, tooth vitality, digital volumetric analysis of structural preservation, survival of restorations, and efficiency of the digital workflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 10-16 years.
- •Permanent molars with moderate or severe MIH (EAPD criteria).
- •Vital and restorable teeth.
- •Ability to attend follow-up visits.
- •Informed consent from guardian + assent from the minor.
排除标准
- •Fluorosis, amelogenesis imperfecta, or other enamel defects.
- •Severe bruxism not controlled.
- •Active extensive caries or irreversible pulpitis.
- •Systemic conditions affecting enamel or healing.
- •Hypersensitivity/allergy to materials/adhesives.
- •Use of analgesics/AINEs <24 h before baseline VAS.
- •Orthodontic bands on the study molar.
研究组 & 干预措施
Graphene-Reinforced CAD/CAM Indirect Restoration
Minimally invasive preparation, composite base build-up when indicated, adhesive protocol with total-etch technique, CAD/CAM fabrication using graphene-reinforced polymer (G-CAM®), adhesive cementation under rubber dam isolation, finishing and polishing, and follow-up at 1 week, 3, 6, and 12 months.
干预措施: Graphene-reinforced CAD/CAM polymer (G-CAM®) (Device)
结局指标
主要结局
Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score
时间窗: 12 months after restoration placement
Clinical performance of the indirect CAD/CAM graphene-reinforced restoration will be evaluated using the FDI World Dental Federation Clinical Criteria. Each domain is scored on a 1-5 ordinal scale, where: 1. = Clinically excellent (best outcome) 2. = Clinically good 3. = Clinically acceptable 4. = Clinically unsatisfactory 5. = Clinically poor (worst outcome) Domains assessed: Marginal integrity Surface roughness/wear Color stability Fractures/chipping Proximal contact Occlusion/function Soft tissue response Higher scores indicate worse clinical performance. Data will be reported as mean score per domain and global acceptability.
Postoperative Sensitivity Measured by Visual Analog Scale (VAS 0-10)
时间窗: Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months
Postoperative sensitivity to cold and mastication will be measured on a 0-10 Visual Analog Scale (VAS), where: 0 = No pain (best outcome) 10 = Worst imaginable pain (worst outcome) Higher scores indicate worse sensitivity.
次要结局
- Patient Satisfaction Measured by 5-Point Likert Scale(1 month, 3 months, 6 months, and 12 months)
- Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³)(Baseline and 12 months)
研究者
Luis Carlos Garza Garza
Restorative and Prosthodontics MSc.
Universitat Internacional de Catalunya