Antimicrobial Activity and Clinical Performance of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- clinical performance
研究概览
简要总结
to investigate the effect of modifying GIC with different formulations on the antibacterial activity and clinical performance in reference to unmodified glass ionomer restorative materials.
详细描述
The study will be a randomized clinical trial, with a 1:1:1 allocation ratio and parallel arms that will enroll children from the outpatient clinic of pediatric dentistry department, Ain shams University Blinding: Enrolled children, assessors and statistician will be blinded. Randomization: block randomization with blocks of 6. A maximum of 2 primary molars per patient will receive the same treatment.
Allocation concealment: Allocation will be done just before placement of a restoration to avoid performance bias during the cavity preparation. The envelope will be only checked after cavity preparation when the filling material will be chosen
Groups Teeth will be randomly allocated to 3 groups all groups will receive the same cavity preparation and then a different restoration.
- Group A: glass ionomer powder will be mixed with chlorhexidine
- Group B: glass ionomer will be mixed with titanium dioxide powder.
- Group C: will be the positive control, glass ionomer with no additives
Sample Size The sample size: A total number is 39 (13 in each group) is calculated using Epicalc program version 1.02 assuming a power of 80 % and alpha=0.05. The sample size is based on percentage of success of ART restorations at 9 months follow up (GIC with chlorhexidine and GIC with miswak) was 60% and 90%, respectively.13
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The teeth will be primary molars selected from patients presented to the outpatient clinic that are
- •Healthy patients.
- •Children having at least one primary molar with only occlusal caries having dentine lesions (ADA caries classification system mostly 1 or 2 please check)
- •Dentine caries must be apparent visually or radiographically
排除标准
- •.Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
- •Patients with history of active para-functional oral habits, xerostomia.
- •Patients who will have difficulties in cooperating
结局指标
主要结局
clinical performance
时间窗: 9 months
the clinical performance of different restorations will be evaluated by USPHS evaluation criteria
次要结局
- antibacterial effect(9 months)
研究者
Mariem Wassel
assistant professor
Ain Shams University