Dental CariesCEPECO3NCT03827889
Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth
A study testing WMP of fluoride varnish, TWLP of fluoride varnish and DHP (educational intervention) in people with Dental Caries, run by Universidade Ibirapuera at 1 site in Brazil.
Trial summary
Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- WMP of fluoride varnish, TWLP of fluoride varnish and DHP (educational intervention)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth
Who cannot join
- Patients with special needs;
- Patients using orthodontic appliances;
- systemic diseases;
- Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
- teeth with spontaneous painful symptomatology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants
- Conditions
- Dental Caries
- Being tested
- WMP of fluoride varnish, TWLP of fluoride varnish, DHP (educational intervention)
- Keywords
- dental caries, Tooth, Deciduous, Fluorides, Topical
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WMP of fluoride varnishProcedure or surgery
Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
TWLP of fluoride varnishProcedure or surgery
application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis
DHP (educational intervention)Behavioural
The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices
| Study group | Role | What they receive |
|---|---|---|
| WMP of fluoride varnish | Experimental | Whole mouth protocol group Receives: Procedure: WMP of fluoride varnish |
| TWLP of fluoride varnish | Experimental | Tooth with lesion Protocol Receives: Procedure: TWLP of fluoride varnish |
| DHP (educational intervention) | Active comparator | Diet and Hygiene guidance Protocol Receives: Behavioral: DHP (educational intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:
- Present progression: Change in radiolucidity area of the Lesion
- Absent progression: No change in the area of radiolucidity of the lesion.
Measured: Every 6 months up to 24 months
Secondary outcomes (3)
Number of surfaces with NEW CARIES LESIONS
Detection of the presence of new lesions in deciduous and permanent teeth through visual inspection after dental cleaning. New lesions will be recorded using ICDAS scores.
Measured: Up to 24 months
Children self-reported discomfort
The child's discomfort will be assessed immediately after the sequence of treatments performed in each session by the Wong-Baker face scale. Each face corresponds to a number in a numeric scale from 0 to 5, being 0 no discomfort and 5 maximum of discomfort. At the end, the averages of each score will be compared between the experimental groups.The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.
Measured: baseline (Immediately after procedure)
COST-EFFICACY of each protocol
To evaluate the cost-efficacy of different protocols by total value in dollar of treatment in relation to efficacy.The quantities of all consumables used in each procedure will be annotated, as well as the time spent in each procedure, money and time will be combined to report the cost of procedures, measured by $/hour. In addition, we will verify the efficacy through the need for new surgical treatments or new caries lesions. In this way, we will compare the experimental groups according to the cost ($/hour) x the efficacy (need for new interventions). The costs of each treatment procedure will be calculated and compared with thresholds values for intervention by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/ en/).
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Outbreak of COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Ibirapuera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Kerber Tedesco, Universidade Ibirapuera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827889
- Sponsor's protocol ID
- UNIB5
- Acronym
- CEPECO3
- Status last verified
- May 2023
- First submitted
- 22 Jan 2019
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on Mendeley database
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03827889
- Acronym / sponsor ID
- CEPECO3 / UNIB5
- Conditions
- Dental Caries
- Keywords
- dental caries, Tooth, Deciduous, Fluorides, Topical
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Outbreak of COVID-19.
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Feb 2019 (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.
Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WMP of fluoride varnish | Experimental | Procedure: WMP of fluoride varnishWhole mouth protocol group |
| TWLP of fluoride varnish | Experimental | Procedure: TWLP of fluoride varnishTooth with lesion Protocol |
| DHP (educational intervention) | Active comparator | Behavioral: DHP (educational intervention)Diet and Hygiene guidance Protocol |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth
Key exclusion criteria (5 listed)
- Patients with special needs;
- Patients using orthodontic appliances;
- systemic diseases;
- Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
- teeth with spontaneous painful symptomatology.
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 |
|---|---|---|
| WMP of fluoride varnishApplication of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found | Procedure or surgery | WMP of fluoride varnish |
| TWLP of fluoride varnishapplication of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis | Procedure or surgery | TWLP of fluoride varnish |
| DHP (educational intervention)The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices | Behavioural | DHP (educational intervention) |
Primary outcome
PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
Time frame: Every 6 months up to 24 months
Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as: * Present progression: Change in radiolucidity area of the Lesion * Absent progression: No change in the area of radiolucidity of the lesion.
3 secondary outcomes
Number of surfaces with NEW CARIES LESIONS
Time frame: Up to 24 months
Children self-reported discomfort
Time frame: baseline (Immediately after procedure)
COST-EFFICACY of each protocol
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on Mendeley database
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WMP of fluoride varnish, TWLP of fluoride varnish and DHP (educational intervention) in people with Dental Caries, run by Universidade Ibirapuera 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 1 inclusion and 5 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: paused, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment) (time frame: Every 6 months up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.