Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Absence of spontaneous pain (questionnaire)
研究概览
简要总结
Untreated dental caries is a worldwide pandemic (Edelstein, 2006). Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries (Baelum et al., 2007).
Traditional treatment of cavitated dentin lesions advocates complete removal of the decayed structure, i.e. the infected and affected dentin layers. During this procedure, however, a significant quantity of the dental structure is removed, and the pulp tissue may be exposed. In light of this, the complete removal of all decayed structures from a tooth with cavitated lesions is no longer seen as mandatory, as this increases the chance of pulp exposure, post-operative pain and weakens the tooth structure, and there is growing evidence to support incomplete removal of decayed tissue prior to the restoration of the cavity. It is argued, however, that carious lesions remaining in the cavity must be completely sealed in order to prevent their progression (Yee et al., 2009).
Arresting Caries Treatment (ACT) has been proposed to oversee untreated dental caries in children of disadvantaged communities. Treatment of carious lesions based on minimally invasive technique methods aim to prevent their progression and preserve pulp vitality by means of standards of anticipation, remineralization and minimal intervention in the dental tissue (Bedi and Sardo-Infirri, 1999).
详细描述
A treatment option has been proposed in the last decade, based on the change in understanding of carious biofilm development and caries progression. Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. This has the added benefit of avoiding pulp exposure and subsequent treatment (Santamaria, Innes, Machiulskiene, Evans, & Splieth, 2014).
There is no clear evidence that leaving soft infected dentine, before sealing the cavity, is deleterious. Instead, this may prevent pulp exposure, preserve the pulp vitality, reduce the permeability of the remaining dentine by stimulating tertiary dentine formation, and so change the environment for the remaining microorganisms and thus arresting caries process. Silver diamine fluoride (SDF), Ag(NH3)2F, has been used to arrest caries since 1969.Silver Diamine Fluoride is a topical drug that is applied clinically to control active dental caries and prevent further progression of disease. Although, the ideal way to treat teeth with decay is removal of the decay and placing a restoration, this alternative treatment allows us to stop decay with non-invasive methods, especially with young children that have primary teeth. Treatment with Silver Diamine Fluoride does not eliminate the need for restorative dentistry to repair function or aesthetics, but has been effective at prevention of further decay.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 4 to 6 years.
- •in good general health.
- •o Have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS* codes 5 or 6*.
- •PREOPERATIVE RADIOGRAPH
- •Absence of periapical infection.
- •No root resorption.
- •Normal periodontal ligament space.
排除标准
- •With systemic or neurological diseases.
- •With a history of allergy to silver or any substance present in the different materials to be used for treatment.
- •Unable to attend follow-up visits. TEETH
- •With spontaneous pain, mobility or radiographic signs of pulpal or periapical infection.
研究组 & 干预措施
silver diamine fluoride
38% silver diamine fluoride applied to cavitated primary molars twice per week to arrest caries
干预措施: Silver Diamine Fluoride (Drug)
interim restorative therapy
Resin modified glass ionomer applied to cavitated primary molars
干预措施: Glass Ionomer (Drug)
结局指标
主要结局
Absence of spontaneous pain (questionnaire)
时间窗: 6 months
Direct questioning (yes/no)
次要结局
- Absence of pain on percussion (clinical examination)(6 months)
- Absence of swelling (clinical examination)(6 months)
- periapical radiograph(6 months)
研究者
Manar Motawie Abdulfattah
principle investigator
Cairo University