The Antimicrobial Activity and Clinical Performance of Chitosan-modified Glass Ionomer: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Antibacterial
研究概览
简要总结
The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars
详细描述
Participants will be recruited from the acquitted to the clinic of pediatric dentistry department , Faculty of Dentistry of Ain Shams University. random allocation of the participants where indirect pulp capping is indicated so that modified Glass ionomer would be used as the filling material.
partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity.
In a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All participants and assessors will be masked,the wil just deal with the randomized numbers.
except the care provider because the materials consistency before mixing is obvious in 2 of the 3 groups
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.
- •Age: 4-8 years.
- •Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm).
排除标准
- •Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
- •Children with systemic diseases.
- •Patients with history of active para-functional oral habits, xerostomia.
- •Patients who will have difficulties in cooperating.
研究组 & 干预措施
Glass ionomer
Stock powder and liquid Fuji IX from GC japan
干预措施: Glass Ionomer (Drug)
Chitosan Glass ionomer
purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan.
will be placed in the prepared cavity over the last layer of caries
干预措施: Glass Ionomer (Drug)
Chitosan Glass ionomer
purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan.
will be placed in the prepared cavity over the last layer of caries
干预措施: Chitosan Low Molecular Weight (20-200 Mpa.S) (Drug)
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid.
The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
干预措施: Glass Ionomer (Drug)
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid.
The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
干预措施: Chitosan Low Molecular Weight (20-200 Mpa.S) (Drug)
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid.
The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
干预措施: Titanium Dioxide (Drug)
Chlorhexidine glass ionomer
Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
干预措施: Glass Ionomer (Drug)
Chlorhexidine glass ionomer
Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
干预措施: Chlorhexidine Diacetate (Drug)
结局指标
主要结局
Antibacterial
时间窗: 9 months
Dentin samples incubated on 2 culture mediums and total bacterial count by counting colony forming units will be counted. Higher number means Less antibacterial effect
Clinical performance
时间窗: followup 9 months
"Modified United States Public Health Service Ryge Criteria" for Direct Clinical Evaluation and rating of Restoration.measuring color match, anatomic contour, marginal integrity, cavosurface marginal discoloration, secondary caries, surface texture, gross fracture. each outcome will be graded Alpha(A) for the highest score, Bravo(b) for moderate score, and Charlie(C) for the lowest score.
次要结局
未报告次要终点
研究者
Omar Assem Hodhod
Principal Investigator,Teaching Assistant ,Dentist
British University In Egypt