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

NCT06999005 | Not Yet Recruiting

• 1 other identifier: 100YEARMOLAR
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Caries Lesion Progression

  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.

  Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months

Secondary Outcomes (1)

• Survival and Integrity of ART Sealants and Restorations

  3, 6, 9, 12, 15, 18, 21, and 24 months

Study Arms (4)

Preventive Varnish Application (Protocol 1)

EXPERIMENTAL

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.

Procedure: Fluoride Varnish Application (Preventive Protocol)

Active White Spot Lesion Treatment (Protocol 2)

EXPERIMENTAL

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.

Procedure: Fluoride Varnish for Active Enamel Lesions

ART Sealant Application (Protocol 3)

EXPERIMENTAL

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.

Procedure: Atraumatic Restorative Treatment (ART) Sealant

Atraumatic Restorative Treatment (Protocol 4)

EXPERIMENTAL

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.

Procedure: Atraumatic Restorative Treatment (ART)

Interventions

Fluoride Varnish Application (Preventive Protocol) PROCEDURE

Single application of Duraphat® fluoride varnish on permanent molars and incisors, repeated every 3 months.

Preventive Varnish Application (Protocol 1)

Fluoride Varnish for Active Enamel Lesions PROCEDURE

Weekly fluoride varnish applications for 4 weeks, followed by quarterly maintenance applications.

Active White Spot Lesion Treatment (Protocol 2)

Atraumatic Restorative Treatment (ART) Sealant PROCEDURE

Sealant placement with high-viscosity glass ionomer using the ART technique, with quarterly fluoride varnish.

ART Sealant Application (Protocol 3)

Atraumatic Restorative Treatment (ART) PROCEDURE

Manual caries removal and cavity restoration with glass ionomer cement, followed by fluoride varnish every 3 months.

Atraumatic Restorative Treatment (Protocol 4)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study due to the visible and procedural nature of the dental interventions performed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share