Clinical trial NCT06999005: Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents
Official title: Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents:A Multicenter Longitudinal Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 2500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This multicenter randomized clinical trial uses a parallel assignment model. After an initial screening of 50,000 children aged 6 to 12 years, approximately 2,500 children with active dental caries lesions will be assigned to one of four treatment arms according to lesion severity and subsequently randomized within the appropriate group. Each participant will receive only one of the four interventions and will be followed for 24 months, with evaluations every three months.
Primary purpose: PREVENTION

Brief summary: This multicenter longitudinal interventional study aims to evaluate the effectiveness of four minimally invasive protocols for the prevention and control of dental caries in children and adolescents. In the first phase, approximately 50,000 children aged 6 to 12 years from five Brazilian cities will undergo dental screening and receive preventive oral health interventions. In the second phase, 2,500 children diagnosed with active caries will be treated with different interventions, depending on lesion severity. All participants will be followed up every three months for 24 months.

Detailed description: This study is a multicenter longitudinal interventional trial coordinated by the Brazilian Society of Pediatric Dentistry (ABOPED) in five Brazilian cities: São Paulo, Curitiba, Brasília, Fortaleza, and Belém. The aim is to assess the effectiveness of four evidence-based minimally invasive protocols for preventing and managing dental caries in children and adolescents, and to propose a replicable public health model for pediatric oral care.

In the first phase, approximately 50,000 children aged 6-12 years will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All children will receive health literacy activities, oral hygiene instructions, toothbrushes, fluoride toothpaste (1,100 ppm), and a single application of fluoride varnish (Duraphat®) to permanent molars and incisors.

Children identified with active caries lesions (ICDAS 1-6) will be considered for the second phase. A total of 2,500 participants will be selected and allocated to one of the following four intervention protocols based on clinical diagnosis:

Protocol 1: Single application of fluoride varnish for prevention. Protocol 2: Four weekly applications of fluoride varnish for active white spot lesions, followed by quarterly applications.

Protocol 3: High-viscosity glass ionomer ART sealants (for ICDAS 3), with quarterly fluoride varnish.

Protocol 4: Conventional atraumatic restorative treatment (ART) with glass ionomer (for ICDAS 4-6), plus quarterly fluoride varnish.

Participants will be followed up every three months over a 24-month period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Caries Lesion Progression
timeFrame: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary outcomes:
measure: Survival and Integrity of ART Sealants and Restorations
timeFrame: 3, 6, 9, 12, 15, 18, 21, and 24 months
Other outcomes:
Locations:
Study officials:
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