Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents

University of Nove de Julho

Status: Not yet enrolling

Conditions: Dental Caries

Treatments: Procedure: Atraumatic Restorative Treatment (ART) Sealant; Procedure: Fluoride Varnish for Active Enamel Lesions; Procedure: Fluoride Varnish Application (Preventive Protocol); Procedure: Atraumatic Restorative Treatment (ART)

Study type: Interventional

Funder types: Other

Identifiers

NCT06999005

100YEARMOLAR

Details and patient eligibility

About

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.

Full description

This study is a multicenter longitudinal interventional trial coordinated by the Brazilian Society of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,500 participants in 4 patient groups

Preventive Varnish Application (Protocol 1)

Experimental group

Description:

Children with no visible carious lesions or early non-cavitated enamel lesions (ICDAS 0 to 2) will receive a single application of Duraphat® fluoride varnish (Colgate®) on first permanent molars and permanent incisors. The varnish will be applied using cotton swabs, following drying of the surfaces. This protocol aims to provide preventive sealing and will be reapplied every three months.

Treatment:

Procedure: Fluoride Varnish Application (Preventive Protocol)

Active White Spot Lesion Treatment (Protocol 2)

Experimental group

Description:

Children diagnosed with active enamel caries lesions (ICDAS 1 to 3) will receive Duraphat® fluoride varnish (Colgate®) in four weekly sessions to promote lesion arrest and remineralization. After lesion inactivation, quarterly reapplications will be performed. For first molars and incisors without lesions but still erupting (with gingival operculum), quarterly varnish applications will also be provided.

Treatment:

Procedure: Fluoride Varnish for Active Enamel Lesions

ART Sealant Application (Protocol 3)

Experimental group

Description:

Children with occlusal lesions classified as ICDAS 3 or at high risk of caries will receive ART sealants (Atraumatic Restorative Treatment) using high-viscosity glass ionomer cement. The protocol includes professional cleaning, relative isolation, placement of the material, finger pressure sealing, and final fluoride varnish application. Quarterly evaluations and varnish reapplications will be conducted.

Treatment:

Procedure: Atraumatic Restorative Treatment (ART) Sealant

Atraumatic Restorative Treatment (Protocol 4)

Experimental group

Description:

Children with dentin-level carious lesions (ICDAS 4 to 6) and pulpal vitality will receive cavity cleaning with cotton pellets and caries removal using manual excavators and PapacarieDUO® gel. The cavity will be restored with high-viscosity glass ionomer cement using finger pressure technique. Fluoride varnish will be applied afterward. Quarterly follow-ups will include clinical evaluation and retreatment if necessary.

Treatment:

Procedure: Atraumatic Restorative Treatment (ART)