To evaluate application of 38 percent silver diamine fluoride in arresting dental caries of permanent teeth using atraumatic restorative treatment ART and conventional GIC restoration An interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Assessment of survival of the restoration clinically using criteria and codes on follow up of 7th, 30th days , 3 months , 6 months.
研究概览
简要总结
This novel approach brings together the capability of Silver Diamine Fluoride (SDF) to kill bacteria with that of Glass ionmer cement (GIC) restoration to seal the tooth and cut off nutrients needed for bacterial growth. As SDF could enhance cariostatic action and prolong the survival of restoration in oral health care settings for resource management in cost effective way.
To evaluate clinical performance and longevity of SDF applied GIC restorations and assess survival rate using ART and conventional GIC method over a period of 6 months for prevention and arrest of caries.
Parallel arm RCT will be conducted - the patients will be randomized into 4 groups and accordingly intervention will be given. The follow up will be done for 6 months.
Individual between 18 to 65 years with class 1 caries of the permanent posterior teeth.
Study will be conducted at department of Public Health Dentistry Government college of dentistry , Indore, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Any individuals, between the age of 18 to 65 years, with Class 1 occlusal caries of posterior teeth, without involving the pulp.
- •2.Patients who are willing to attend the follow-up visit as required for the study.
- •3.Patients understand the significance of SDF for the treatment and prevention of tooth decay and giving consent.
排除标准
- •1.Patients with developmental abnormalities of enamel and dentin.
- •2.Patient with systemic illness.
- •3.Patients with known silver allergic reactions.
- •4.Pulp-exposed tooth, or any kind of iatrogenic deep dentinal pulpal exposure.
- •5.Pregnant and lactating women will not be included in study.
- •6.Patients with symptomatic oral mucosal lesions.
- •7.Patients with periodontal disease.
结局指标
主要结局
Assessment of survival of the restoration clinically using criteria and codes on follow up of 7th, 30th days , 3 months , 6 months.
时间窗: Analysis of survival rate and caries arrest in 4 groups will be compared at baseline, 7 days, 30 days , 3 months and 6 months.
And at the end of 6th month radiograph taken to assess the caries arrest using baseline radiograph will be done.
时间窗: Analysis of survival rate and caries arrest in 4 groups will be compared at baseline, 7 days, 30 days , 3 months and 6 months.
次要结局
- To evaluate the cost effectiveness after completion of study(After 6 months , 1 year)
研究者
Nandani Tiwari
Government College of Dentistry, Indore,MP