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临床试验/NCT05624008
NCT05624008招募中不适用

Clinical Performance of Bioactive Bioceramic Glass Ionomer Restorations vs Conventional High Viscous Glass Ionomer Restorations in Geriatric Patients With Carious Cervical Lesions: A One Year Randomized Clinical Trial.

Cairo University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
2
主要终点
Change in Marginal adaptation score

研究概览

简要总结

The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.

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
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Geriatric patients aged above 55 years
  • Patients with untreated carious lesions
  • Patients who have at least 20 teeth under occlusion
  • Patients with normal occlusion
  • Vital teeth with carious cervical lesion with asymptomatic vital pulp.
  • Teeth with no or minimum mobility.
  • Teeth with normal occlusion.
  • Teeth with surrounding healthy gingiva and supporting-structures.

排除标准

  • Patients who are unable to return for recall appointments
  • Presence of abnormal oral, medical or mental conditions.
  • Patients with severe medical diseases.
  • Patients with xerostomia
  • Patients with parafunctional habits.
  • Non vital teeth.
  • Teeth with signs or symptoms of pulpitis.
  • Teeth with non carious lesions.

结局指标

主要结局

Change in Marginal adaptation score

时间窗: Baseline, 3 months, 6 months, 12 months

Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

次要结局

  • Change in Retention score(Baseline, 3 months, 6 months, 12 months)
  • Change in Color match score(Baseline, 3 months, 6 months, 12 months)
  • Change in Marginal discoloration score(Baseline, 3 months, 6 months, 12 months)
  • Change in Secondary caries score(Baseline, 3 months, 6 months, 12 months)
  • Change in Wear score(Baseline, 3 months, 6 months, 12 months)
  • Change in Postoperative hypersensitivity score(Baseline, 3 months, 6 months, 12 months)

研究者

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

Mariam Mohammed Abd Al-Naieem

Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry

Cairo University

研究点 (2)

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