Longitudinal Evaluation of Minimally Invasive Protocols for Dental Caries in Brazilian Schoolchildren

Официальное название

Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Fluoride Varnish Application (Preventive Protocol)
  Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.
• Процедура Fluoride Varnish for Active Enamel Lesions
  Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.
• Процедура Atraumatic Restorative Treatment (ART) Sealant
  Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.
• Процедура Atraumatic Restorative Treatment (ART)
  Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.

Первичные конечные точки

• Control of Caries Activity [Срок оценки: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months]

Вторичные конечные точки (3)

• Survival and Integrity of ART Sealants and Restorations [Срок оценки: 3, 6, 9, 12, 15, 18, 21, and 24 months]
• Inactivation of Active White Spot Lesions [Срок оценки: 3, 6, 9, 12, 15, 18, 21, and 24 months]
• Adherence to Preventive Oral Health Measures [Срок оценки: 3, 6, 9, 12, 15, 18, 21, and 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Universidade Metropolitana de Santos - UNIMES — Santos

Идентификаторы

NCT: NCT06999005 · 100YEARMOLAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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