Comparison of Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Mexican Schoolchildren: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Incidence of coronal caries lesions
研究概览
简要总结
The objective of this clinical trial is to compare the efficacy of three preventive methods in reducing the incidence of coronal caries in the first permanent molars of Mexican schoolchildren.
The main question to be answered is:
Which of the preventive methods (application of fluoride varnish (control group), application of a conventional pit and fissure sealant (glass ionomer) plus fluoride varnish, or application of a pit and fissure sealant with Giomer® technology) will be more effective in preventing coronal caries in the first permanent molars of Mexican schoolchildren?
Hypothesis: The incidence of coronal caries with the application of a conventional pit and fissure sealant (glass ionomer) plus fluoride varnish will be lower compared to the application of a pit and fissure sealant with Giomer® technology and compared to the application of fluoride varnish (control group).
Three groups will be formed (68 participants each): one group will receive the application of sodium fluoride varnish (control group), a second group will receive the application of conventional pit and fissure sealant (glass ionomer) plus sodium fluoride varnish, and a third group will receive the application of pit and fissure sealant with Giomer® technology.
All groups will receive dental health education (importance of oral health, information about dental caries, oral hygiene practices, and information about coronal caries prevention). Preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18 and 24 months. The incidence of coronal caries between groups will be compared with the presence of surfaces with progression of caries in the first permanent molars.
The best preventive method can be proposed for use in caries prevention programmes in schoolchildren. The results will provide elements for the dental surgeon in decision-making to prevent caries lesions in schoolchildren.
详细描述
Dental caries is one of the most prevalent diseases in children worldwide. Untreated dental caries has economic and social repercussions, can affect academic performance, and negatively impact quality of life. Because of this situation, the search for an effective and efficient preventive agent for coronal caries is very important.
Currently, it is not possible to establish which type of pit and fissure sealant is best in terms of efficacy for caries prevention in first permanent molars. The application of preventive agents with Giomer® technology appears to be a promising alternative compared to existing alternatives. However, there is very little scientific evidence regarding the efficacy of pit and fissure sealants with Giomer® technology for caries prevention and their relative efficacy compared to other types of sealants. Furthermore, the evidence is limited and inconclusive regarding the efficacy of pit and fissure sealant plus fluoride varnish compared to pit and fissure sealant alone.
The use of pit and fissure sealants in school-aged children and the promotion of self-care practices should be included in prevention programs. The large proportion of children with treatment needs at the state and national levels emphasizes the need for oral health programs to reduce the incidence and prevalence of caries, as rehabilitation costs represent a significant burden for both families and health systems.
Hypothesis: The incidence of coronal caries in permanent first molars with the application of a conventional pit and fissure sealant (glass ionomer) plus fluoride varnish will be lower compared to the incidence of coronal caries in permanent first molars with the application of a pit and fissure sealant using Giomer® technology, and compared to the incidence of coronal caries in permanent first molars with the application of fluoride varnish (control group) after 24 months of follow-up.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schoolchildren between 6 and 8 years of age, of both sexes, with at least one erupted permanent first molar, healthy or with incipient caries (ICDAS codes 1 and 2), attending public primary schools in the State of Mexico located in the municipality of Nezahualcóyotl.
- •Schoolchildren with a moderate or high risk of tooth decay according to the caries risk assessment.
排除标准
- •Schoolchildren with the presence of incisor-molar hypomineralization or dental fluorosis.
- •Schoolchildren with the presence of sealants of fissures and fissures or with a history of their placement in any of the first permanent molars.
- •School children who have a disability that prevents them from performing the oral clinical examination or interview.
- •Schoolchildren with allergies or suspected allergies to milk protein and its derivatives, methacrylate monomer and/or acetone.
结局指标
主要结局
Incidence of coronal caries lesions
时间窗: 24 months
New lesions with caries progression
次要结局
未报告次要终点
研究者
Aida Borges
Aida Borges-Yañez, PhD
Universidad Nacional Autonoma de Mexico