Randomized Clinical Trial to Evaluate the Impact on Oral Health of the "Oral Health Package Law" (School Daily Brushing Program) Combined, or Not, With Fluor Varnish Application on Schoolchildren of Mérida, Mexico.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Impact on oral health
研究概览
简要总结
Study aimed at evaluating the impact on oral health of the "Ley del Paquete de Salud Bucal" (daily school brushing program) combined, or not, with the application of fluoride varnish in schoolchildren from 6 to 8 years old who attend public elementary schools in Mérida,
Mexico. with a two-year follow-up (2023-2025).
详细描述
First visit:
The child will be asked to report to the school clinic to be screened by the dentist and/or hygienist to determine if he or she is a suitable test subject. If the parents and the child decide to participate and is accepted into the study, the family need to follow a specific set of instructions. The child will not perform or receive any oral hygiene (other than that described below).
At the beginning of the study, the child's teeth and gums will be examined to determine if they are eligible to participate in the study. The parents/tutors will agree to use only the fluoride toothpaste provided for the duration of the study and will be required to brush
their teeth daily in the school setting. There will be no restrictions regarding eating habits. A clinical score will be made to assess the level of caries, gingivitis and plaque level of all teeth and will be recorded on the evaluation forms. Questionnaires will be completed, and the child will be provided with a medium soft-bristled toothbrush and a tube of household toothpaste. Supervised brushing will be performed by asking the child to coat the
toothbrush head with their assigned toothpaste and brush their teeth for two (2) minutes. Subsequently, the child may receive a topical application of fluoride varnish depending on which group they belong to in this clinical trial.
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 (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to the treatment allocation of the participants. Coded data sheets are used to maintain the blinding
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
- •Men and women, between 6-8 years of age;
- •Children enrolled in first, second and third grade of primary education
- •Availability during the duration of the study;
- •Good general health (absence of any condition that, in the opinion of the Principal Investigator, could constitute a risk to the subject while participating in the study.
- •5 Examples include heart problems, valve/hip replacements, etc.);
- •6 Willingness to provide information related to his medical history;
- •7 Informed consent form signed by the caregiver;
- •8 Informed consent signed by the child
排除标准
- •1 Subjects must not have any of the following:
- •2 The caregiver is unwilling to sign the informed consent form
- •3 Subject participating in any other clinical study;
- •Subject allergic to oral care products, consumer personal care products or their ingredients;
- •Subjects with orthodontic bands, removable partial dentures, tumors of the hard parts or soft tissue of the oral cavity, or advanced periodontal disease
- •Continued use of medications known to affect gingival tissues (ie, calcium channel blockers, phenytoin, cyclosporine);
- •Subject is currently receiving chemotherapy
- •Subject has leukemia
研究组 & 干预措施
Test Group
Fluoride toothpaste and fluoride varnish
干预措施: Fluoride varnish (Drug)
Control Group
Fluoride toothpaste
干预措施: Fluoride toothpaste (Drug)
结局指标
主要结局
Impact on oral health
时间窗: 24 months
To evaluate the impact on oral health of the "Ley del Paquete de Salud Bucal" (daily school brushing program) combined, or not, with the application of fluoride varnish in schoolchildren from 6 to 8 years old who attend public elementary schools in Mérida, Mexico.
次要结局
- Gingivitis assessment(24 months)
- Plaque assessment(24 months)
- Caries assessment(24 months)
研究者
Mildred Beatriz Salas Ley
DDS orthodontic specialist
Anahuac Mayab University