Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Incidence of root caries lesions
研究概览
简要总结
Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level.
A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions.
Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish.
Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels.
Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive.
If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.
详细描述
There is an increase in the incidence and prevalence of chronic diseases, including oral problems in older persons. Coronal and root caries, and periodontitis represent the main causes of tooth loss, and in older adults they have a great impact on quality of life, nutritional status, social life, and the increased risk of systemic problems related to dental infectious processes. At present, older adults have more remaining teeth and dental caries is highly prevalent. It is important to investigate and implement methods that prevent the formation of new carious lesions and that arrest existing lesions. The utilization of silver diamine fluoride as a method to prevent coronal caries has been recognized and has proven to be highly effective in treating dentin hypersensitivity and arresting active lesions, also it is easy to apply. Therefore, it is important and necessary to implement methods that avoid the formation of lesions and that inhibit the root caries lesions already present.
If greater effectiveness of silver diamine fluoride in preventing and arresting active root caries is confirmed, its use in conjunction with oral health education can be proposed as a preventive method to be included in oral health programs in institutionalized persons in whom dental care and attention are less frequent. Its ease of application, the longer time between applications and its cost can facilitate better oral care. On the other hand, the results can guide professionals in clinical practice in making decisions regarding the most appropriate method to prevent and arrest root caries lesions in their patients.
Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be lower on root surfaces that have been treated with silver diamine fluoride solution (38% concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22,600 ppm]) and to those in the control group (artificial saliva).
The number of active root caries lesions arrested at baseline will be higher in people who have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and with the control group (artificial saliva).
General objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will not know which type of fluoride they are getting. Outcome assesor will not know the type of fluoride or placebo assigned to each group
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 60 years of age and older
- •At least 5 teeth with gingival recession and exposed root surfaces not indicated for extraction
- •No problems performing activities of daily living
- •Agree to participate and sign the informed consent.
排除标准
- •Health problems that prevent oral hygiene
- •Cognitive problems that prevent understanding oral hygiene instructions
- •Salivary gland diseases (hyposalivation)
- •Having received radiation therapy to the head and neck
- •Active infections of the oral mucosa
- •Allergy to silver
- •Stomatitis
- •Allergy to colophony (component of varnishes)
- •Elimination criteria:
- •Adults who do not return to subsequent applications of silver diamine fluoride, sodium fluoride varnish, or artificial saliva.
结局指标
主要结局
Incidence of root caries lesions
时间窗: 30 months
Number of new caries lesions
次要结局
- Arrested root caries lesions(30 months)
研究者
Aida Borges
Principal investigator
Universidad Nacional Autonoma de Mexico