Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Control of Caries Activity
研究概览
简要总结
This multicenter longitudinal interventional study aims to evaluate minimally invasive protocols for the prevention and control of dental caries in Brazilian schoolchildren under routine public health conditions. In the first phase, 50,000 children aged 6 to 12 years from public schools in five Brazilian cities will undergo dental screening using ICDAS criteria and receive preventive and educational oral health measures. In the longitudinal treatment phase, 2,500 children diagnosed with active carious lesions will be managed according to ICDAS-based minimally invasive treatment protocols. Participants will be followed every three months for up to 24 months.
详细描述
This is a pragmatic, multicenter, non-randomized, longitudinal interventional study coordinated by the Brazilian Association of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, Brasília, Fortaleza, and Belém. The study aims to evaluate the longitudinal clinical behaviour of carious lesions and the performance of minimally invasive oral health strategies under routine school-based public health conditions.
In the first phase, 50,000 children aged 6-12 years enrolled in public schools will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All participants will receive preventive and educational measures, including oral health counselling, supervised toothbrushing with fluoridated toothpaste (1100 ppm F), toothbrushes, toothpaste, and application of Duraphat® fluoride varnish to permanent molars and incisors.
Children identified with active carious lesions classified as ICDAS 1-6 and meeting the eligibility criteria will enter the longitudinal minimally invasive treatment phase. A total of 2,500 participants will be managed according to ICDAS-based treatment protocols:
Protocol 1: preventive fluoride varnish application; Protocol 2: fluoride varnish applications for active white spot lesions; Protocol 3: ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions; Protocol 4: atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® during selective caries removal.
Participants will be followed every three months for up to 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study due to the visible and procedural nature of the dental interventions performed.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 6 and 12 years at the time of enrollment
- •Presence of at least one erupted permanent first molar
- •Diagnosis of active caries lesions classified according to ICDAS (scores 1 to 6)
- •Written informed consent signed by a legal guardian and assent signed by the child
- •Ability to attend quarterly follow-up visits over a 24-month period
排除标准
- •Children requiring endodontic treatment or presenting extensive pulpal involvement
- •Presence of systemic diseases or medical conditions that contraindicate dental care
- •Known allergy to any material used in the study (fluoride varnish, high-viscosity glass ionomer cement)
- •Participation in other clinical dental studies that could interfere with the outcomes
研究组 & 干预措施
Preventive Varnish Application (Protocol 1)
Children with erupting or erupted permanent first molars and incisors will receive preventive application of Duraphat® fluoride varnish (Colgate®). The varnish will be applied after surface cleaning and drying, with quarterly maintenance applications during follow-up.
干预措施: Fluoride Varnish Application (Preventive Protocol) (Procedure)
Active White Spot Lesion Treatment (Protocol 2)
Children diagnosed with active non-cavitated enamel lesions (ICDAS 1 to 2) will receive Duraphat® fluoride varnish (Colgate®) in four weekly sessions to promote lesion arrest and remineralization, followed by quarterly maintenance applications during follow-up.
干预措施: Fluoride Varnish for Active Enamel Lesions (Procedure)
ART Sealant Application (Protocol 3)
Children with occlusal carious lesions classified as ICDAS 3 on first permanent molars will receive ART sealants using high-viscosity glass ionomer cement. The protocol includes surface cleaning, relative isolation, placement of the material using finger pressure technique, and fluoride varnish application. Quarterly evaluations and maintenance applications will be performed during follow-up.
干预措施: Atraumatic Restorative Treatment (ART) Sealant (Procedure)
Atraumatic Restorative Treatment (Protocol 4)
Children with dentin carious lesions classified as ICDAS 4 to 6 and preserved pulp vitality will receive atraumatic restorative treatment (ART) using hand instruments and high-viscosity glass ionomer cement. PapacarieDUO® may be optionally used to facilitate selective caries removal according to clinical indication. Fluoride varnish will be applied after treatment, with quarterly follow-up evaluations throughout the study period.
干预措施: Atraumatic Restorative Treatment (ART) (Procedure)
结局指标
主要结局
Control of Caries Activity
时间窗: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months
Assessment of caries activity control using International Caries Detection and Assessment System (ICDAS) criteria during longitudinal follow-up. Control of caries activity will be defined according to the absence of lesion progression, reduction in lesion activity, or maintenance/arrest of carious lesions over time.
次要结局
- Inactivation of Active White Spot Lesions(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Adherence to Preventive Oral Health Measures(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Survival and Integrity of ART Sealants and Restorations(3, 6, 9, 12, 15, 18, 21, and 24 months)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho