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临床试验/NCT04266210
NCT04266210已完成不适用

Clinical Evaluation Two Restorative Systems in Non-carious Cervical Lesions at Patients With Different Systemic Diseases

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Clinical performances of different restoratiove systems

研究概览

简要总结

The clinical performances of a restorative glass ionomer and a composite resin will be compared in the restoration of non-carious cervical lesions (NCCLs) at patients with systemic diseases.

After recruiting participants with at least 2 NCCLs and at least one systemic disease, all restorations will be placed by a single clinician. All lesions will be cleaned before restoring.

NCCLs will be divided into two groups: a conventional restorative glass ionomer cement [Fuji Bulk (GC, Tokyo Japan) (FB)] and a posterior composite resin [G-ænial Posterior (GC, Tokyo Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with at least one systemic disease such as hypertension, cancer in remission after chemotherapy or radiotherapy, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.
  • Patients using medications for hypertension, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.
  • Patients who are able to attend recall appointments.
  • Age greater than 18 years who had at least one systemic disease At least two NCCLs needed to be restored.
  • At least 20 teeth in occlusion.

排除标准

  • Non-vital teeth
  • Mobility of teeth
  • Severe periodontal disease
  • Heavy bruxism habit

结局指标

主要结局

Clinical performances of different restoratiove systems

时间窗: two years

Two year results according to USPHS criteria

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

Dr. Fatma Dilşad Öz

Assistant Professor

Hacettepe University

研究点 (1)

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