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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Bioceramic glass ionomer restoration
Experimental
Calcium aluminate modified glass ionomer
干预措施: Bioceramic glass ionomer restoration (Other)
Resin modified glass ionomer restoration
Active Comparator
type II resin modified glass ionomer cement
干预措施: Resin modified glass ionomer restoration (Other)
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
Mariam Mohammed Abd Al-Naieem
Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry
Cairo University
研究点 (1)
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