Dental CariesNCT06999005
Longitudinal Evaluation of Minimally Invasive Protocols for Dental Caries in Brazilian Schoolchildren
A study testing Fluoride Varnish Application (Preventive Protocol), Fluoride Varnish for Active Enamel Lesions and Atraumatic Restorative Treatment (ART) Sealant in people with Dental Caries, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride Varnish Application (Preventive Protocol), Fluoride Varnish for Active Enamel Lesions and Atraumatic Restorative Treatment (ART) Sealant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elaine M Santos contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Metropolitana de Santos - UNIMES
Santos, São Paulo, 11045-002
Sandra Kalil, sandra.skb@gmail.com
About this study
Official title: Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol
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.
Read the detailed description
This is a pragmatic, multicenter, non-randomized, longitudinal interventional study coordinated by the Brazilian Association of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, Brasília, Fortaleza, and Belém. The study aims to evaluate the longitudinal clinical behaviour of carious lesions and the performance of minimally invasive oral health strategies under routine school-based public health conditions.
In the first phase, 50,000 children aged 6-12 years enrolled in public schools will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All participants will receive preventive and educational measures, including oral health counselling, supervised toothbrushing with fluoridated toothpaste (1100 ppm F), toothbrushes, toothpaste, and application of Duraphat® fluoride varnish to permanent molars and incisors.
Children identified with active carious lesions classified as ICDAS 1-6 and meeting the eligibility criteria will enter the longitudinal minimally invasive treatment phase. A total of 2,500 participants will be managed according to ICDAS-based treatment protocols:
Protocol 1: preventive fluoride varnish application; Protocol 2: fluoride varnish applications for active white spot lesions; Protocol 3: ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions; Protocol 4: atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® during selective caries removal.
Participants will be followed every three months for up to 24 months.
- Conditions
- Dental Caries
- Being tested
- Fluoride Varnish Application (Preventive Protocol), Fluoride Varnish for Active Enamel Lesions, Atraumatic Restorative Treatment (ART) Sealant, Atraumatic Restorative Treatment (ART)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride Varnish Application (Preventive Protocol)Procedure or surgery
Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.
Fluoride Varnish for Active Enamel LesionsProcedure or surgery
Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.
Atraumatic Restorative Treatment (ART) SealantProcedure or surgery
Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.
Atraumatic Restorative Treatment (ART)Procedure or surgery
Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Atraumatic Restorative Treatment (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary outcomes (3)
Survival and Integrity of ART Sealants and Restorations
Assessment of the clinical survival and integrity of ART sealants and restorations according to the criteria proposed by Amorim et al. (2014), including evaluation of marginal defects, fractures, retention, and restoration failure over follow-up.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Inactivation of Active White Spot Lesions
Assessment of the inactivation of active white spot lesions following fluoride varnish applications during follow-up evaluations.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Adherence to Preventive Oral Health Measures
Assessment of adherence to supervised toothbrushing, use of fluoridated toothpaste, and attendance at scheduled follow-up visits throughout the study period.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start28 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
- Investigators
- Sandra K Bussadori, Principal investigator, Universidade Metropolitana de Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999005
- Sponsor's protocol ID
- 100YEARMOLAR
- Status last verified
- May 2026
- First submitted
- 14 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bussadori SK, Santos EM, Ferri EP, Chibinski ACR, Pereira LDSV, Ribeiro CDPV, Oliveira GRC, Barbieri DSV, Duran CCG, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Sobral APT, Machado MA. Longitudinal evaluation of minimally invasive protocols for the prevention and control of dental caries in Brazilian schoolchildren: a multicentre study protocol. BMJ Open. 2026 Sep 25;16(9):e118205. doi: 10.1136/bmjopen-2026-118205.
PubMed 42790920
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol
- ClinicalTrials.gov ID
- NCT06999005
- Acronym / sponsor ID
- 100YEARMOLAR
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pragmatic, multicenter, non-randomized, longitudinal interventional study coordinated by the Brazilian Association of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, Brasília, Fortaleza, and Belém. The study aims to evaluate the longitudinal clinical behaviour of carious lesions and the performance of minimally invasive oral health strategies under routine school-based public health conditions.
In the first phase, 50,000 children aged 6-12 years enrolled in public schools will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All participants will receive preventive and educational measures, including oral health counselling, supervised toothbrushing with fluoridated toothpaste (1100 ppm F), toothbrushes, toothpaste, and application of Duraphat® fluoride varnish to permanent molars and incisors.
Children identified with active carious lesions classified as ICDAS 1-6 and meeting the eligibility criteria will enter the longitudinal minimally invasive treatment phase. A total of 2,500 participants will be managed according to ICDAS-based treatment protocols:
Protocol 1: preventive fluoride varnish application; Protocol 2: fluoride varnish applications for active white spot lesions; Protocol 3: ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions; Protocol 4: atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® during selective caries removal.
Participants will be followed every three months for up to 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preventive Varnish Application (Protocol 1) | Experimental | Procedure: Fluoride Varnish Application (Preventive Protocol)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. |
| Active White Spot Lesion Treatment (Protocol 2) | Experimental | Procedure: Fluoride Varnish for Active Enamel LesionsChildren 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. |
| ART Sealant Application (Protocol 3) | Experimental | Procedure: Atraumatic Restorative Treatment (ART) SealantChildren 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. |
| Atraumatic Restorative Treatment (Protocol 4) | Experimental | Procedure: Atraumatic Restorative Treatment (ART)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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride Varnish Application (Preventive Protocol)Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications. | Procedure or surgery | Preventive Varnish Application (Protocol 1) |
| Fluoride Varnish for Active Enamel LesionsFour weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications. | Procedure or surgery | Active White Spot Lesion Treatment (Protocol 2) |
| Atraumatic Restorative Treatment (ART) SealantPlacement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications. | Procedure or surgery | ART Sealant Application (Protocol 3) |
| Atraumatic Restorative Treatment (ART)Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications. | Procedure or surgery | Atraumatic Restorative Treatment (Protocol 4) |
Primary outcome
Control of Caries Activity
Time frame: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months
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.
3 secondary outcomes
Survival and Integrity of ART Sealants and Restorations
Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months
Inactivation of Active White Spot Lesions
Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months
Adherence to Preventive Oral Health Measures
Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42790920Bussadori SK, Santos EM, Ferri EP, Chibinski ACR, Pereira LDSV, Ribeiro CDPV, Oliveira GRC, Barbieri DSV, Duran CCG, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Sobral APT, Machado MA. Longitudinal evaluation of minimally invasive protocols for the prevention and control of dental caries in Brazilian schoolchildren: a multicentre study protocol. BMJ Open. 2026 Sep 25;16(9):e118205. doi: 10.1136/bmjopen-2026-118205.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine M Santos contact
Sandra K Bussadori principal investigator
Universidade Metropolitana de Santos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride Varnish Application (Preventive Protocol), Fluoride Varnish for Active Enamel Lesions and Atraumatic Restorative Treatment (ART) Sealant in people with Dental Caries, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra K Bussadori (+55 11 3385-9241, sandra.skb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of Caries Activity (time frame: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.