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

NCT06999005 | Recruiting

• 1 other identifier: 100YEARMOLAR
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Control of Caries Activity

  Assessment of caries activity control using International Caries Detection and Assessment System (ICDAS) criteria during longitudinal follow-up. Control of caries activity will be defined according to the absence of lesion progression, reduction in lesion activity, or maintenance/arrest of carious lesions over time.

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

Secondary Outcomes (3)

• Survival and Integrity of ART Sealants and Restorations

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

• Inactivation of Active White Spot Lesions

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

• Adherence to Preventive Oral Health Measures

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

Study Arms (4)

Preventive Varnish Application (Protocol 1)

EXPERIMENTAL

Children with erupting or erupted permanent first molars and incisors will receive preventive application of Duraphat® fluoride varnish (Colgate®). The varnish will be applied after surface cleaning and drying, with quarterly maintenance applications during follow-up.

Procedure: Fluoride Varnish Application (Preventive Protocol)

Active White Spot Lesion Treatment (Protocol 2)

EXPERIMENTAL

Children diagnosed with active non-cavitated enamel lesions (ICDAS 1 to 2) will receive Duraphat® fluoride varnish (Colgate®) in four weekly sessions to promote lesion arrest and remineralization, followed by quarterly maintenance applications during follow-up.

Procedure: Fluoride Varnish for Active Enamel Lesions

ART Sealant Application (Protocol 3)

EXPERIMENTAL

Children with occlusal carious lesions classified as ICDAS 3 on first permanent molars will receive ART sealants using high-viscosity glass ionomer cement. The protocol includes surface cleaning, relative isolation, placement of the material using finger pressure technique, and fluoride varnish application. Quarterly evaluations and maintenance applications will be performed during follow-up.

Procedure: Atraumatic Restorative Treatment (ART) Sealant

Atraumatic Restorative Treatment (Protocol 4)

EXPERIMENTAL

Children with dentin carious lesions classified as ICDAS 4 to 6 and preserved pulp vitality will receive atraumatic restorative treatment (ART) using hand instruments and high-viscosity glass ionomer cement. PapacarieDUO® may be optionally used to facilitate selective caries removal according to clinical indication. Fluoride varnish will be applied after treatment, with quarterly follow-up evaluations throughout the study period.

Procedure: Atraumatic Restorative Treatment (ART)

Interventions

Fluoride Varnish Application (Preventive Protocol) PROCEDURE

Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.

Preventive Varnish Application (Protocol 1)

Fluoride Varnish for Active Enamel Lesions PROCEDURE

Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.

Active White Spot Lesion Treatment (Protocol 2)

Atraumatic Restorative Treatment (ART) Sealant PROCEDURE

Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.

ART Sealant Application (Protocol 3)

Atraumatic Restorative Treatment (ART) PROCEDURE

Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.

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

Study Sites (1)

Universidade Metropolitana de Santos - UNIMES

Santos, São Paulo, 11045-002, Brazil

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Sandra K Bussadori

  Universidade Metropolitana de Santos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra K Bussadori

CONTACT

+55 11 3385-9241; sandra.skb@gmail.com

Elaine M Santos

CONTACT

+55 13 3228-3400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will not be randomized. After screening of 50,000 children aged 6 to 12 years, 2,500 children diagnosed with active dental caries lesions will enter the longitudinal minimally invasive treatment phase and will be managed according to ICDAS-based treatment protocols defined by lesion severity and clinical indication. Participants will receive the clinically appropriate minimally invasive protocol and will be followed every three months for up to 24 months.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 31, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)