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

Not Applicable

Not yet recruiting

• Conditions: Dental Caries

• Registration Number: NCT06999005
• Lead Sponsor: University of Nove de Julho

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.

Study Timeline

• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Study Start: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caries Lesion Progression	Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months	Evaluation of changes in caries severity using the International Caries Detection and Assessment System (ICDAS) criteria, comparing baseline scores with follow-up assessments. Progression will be considered when there is an increase in the ICDAS score for the same tooth surface, or development of new lesions.

Secondary Outcome Measures

Name	Time	Method
Survival and Integrity of ART Sealants and Restorations	3, 6, 9, 12, 15, 18, 21, and 24 months	To evaluate the clinical success and longevity of sealants and restorations placed using the Atraumatic Restorative Treatment (ART) technique, according to the criteria described by Amorim et al. (2014). Each restoration will be scored from 0 (satisfactory) to 9 (not possible to evaluate), with intermediate codes for marginal defects, fractures, or missing restorations.