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临床试验 NCT07309653 针对Tooth Injuries，Dental Restoration, Permanent目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth 23 观察性

招募中
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临床试验NCT07309653是一项针对Tooth Injuries，Dental Restoration, Permanent的观察研究试验，目前试验状态为招募中。试验始于2025年12月16日，计划招募23名患者。该研究由曼尼托巴大学主导，预计于2027年10月28日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月2日。
简要概括

The goal of this observational study is to evaluate the clinical performance of a single-shade composite resin, used with an injection moulding technique, in restoring maxillary incisors affected by traumatic dental injury in patients aged 6-15 years.

The main questions it aims to answer are:

  • How well does a single composite resin colour match the natural tooth?
  • How stable is the colour over a 6- and 12-month f...
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官方标题

Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation

疾病
Tooth InjuriesDental Restoration, Permanent
其他研究标识符
  • MU-DT/PY-IRB 2025/082.3010
NCT编号
NCT07309653
实际开始日期
2025-12-16
最近更新发布
2026-01-02
预计完成日期
2027-10-28
计划入组人数
23
研究类型
观察研究
试验状态
招募中
关键词
Patient satisfaction
Color stability
Color matching
Single shade composter resins
Injection moulding technique
Flowable composite resins
Dental trauma
试验组/干预措施
参与者组/试验组干预措施/治疗方法
Test
Restoring with an injectable single shade composite resin using an injectable moulding technique
不适用
主要终点
结果指标度量标准描述时间框架
Colour matching
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Immediate, 1-week, 6-month, 12-month after restoration
Colour stability
Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.
1-week, 6-month, 12-month after restoration
次要终点
结果指标度量标准描述时间框架
Patient satisfaction
Patients show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
1-week, 6-month, 12-month after restoration
Parent satisfaction
Parents show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
1-week, 6-month, 12-month after restoration
参与助手
资格标准

适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
接受健康志愿者
是
  • Children who exhibit cooperative dental behaviours (rating 3 and 4) according to Frankl's behaviour rating scale (Frankl et al. 1962)
  • Presence of at least one maxillary anterior permanent tooth with one-third of crown structure loss from dental trauma
  • The affected tooth must be vital or have undergone vital pulp therapy (e.g., pulpotomy with Calcium hydroxide, white-MTA, or Biodentine)

  • Known allergy to methacrylate-based materials
  • Presence of parafunctional habits, such as bruxism
  • Presence of rampant caries
  • Presence of signs of hypomineralisation, such as post-eruptive breakdown, hypersensitivity, changes in enamel texture and hardness, and abnormal translucency on radiographs.
  • The affected tooth is classified as having moderate or severe discolouration according to Dean's fluorosis index (Dean, 1942)
  • The affected tooth has lost less than one-third of its coronal crown structure
  • The affected tooth has a fracture located at the subgingival margin
  • The affected tooth requires splinting due to the severity of the trauma
  • Presence of severe malocclusion that could compromise the integrity of the restoration
Mahidol University logo曼尼托巴大学
研究责任方
Sawanya Prutthithaworn, 主要研究者, Principal Investigator, Mahidol University
研究中心联系人
联系人: Sawanya Prutthithaworn Dr, PhD, +662-200-7821, [email protected]
1 位于 1 个国家/地区的研究中心
Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand
Sawanya Prutthithaworn, Dr, 联系人, +662-200-7821, [email protected]
招募中