The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
研究概览
简要总结
The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.
详细描述
To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.
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
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
- •The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
- •Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
- •Selected primary teeth must have an anticipated exfoliation date greater than 12 months away
排除标准
- •Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
- •Severe medical conditions that do not allow the child to be managed in the clinic
- •Known allergy /sensitivity to dental materials being used, including SDF
- •Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
- •Wards of the State, for consenting reasons
结局指标
主要结局
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
时间窗: 12 Months
Color of the cavity at the end of the trial
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
时间窗: 12 Months
Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Caries Arrest of Teeth in the SDF Group Measured by Change in Size
时间窗: 12 Months
Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
时间窗: 12 Months
Secondary caries, lost restorations, or restorations needing repair are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
时间窗: 12 Months
Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested). Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.
次要结局
- Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)(Baseline)
- Costs of Treatment (Dollars)(Baseline)
- Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)(Baseline)
- Time of Treatment Procedures (Duration of Time in Minutes)(Baseline)
- Parent Assessment of Appearance of Child's Teeth(12 Months)
- Parent Assessment of Treatment Provided(12 Months)
- Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)(12 Months)
- Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)(Baseline)
- Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)(12 Months)
研究者
Margherita Fontana
Professor
University of Michigan