Dental CariesNCT03005405
Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars
A study testing Ionomer Sealant (test) and Oral hygiene orientation and professional fluoride application in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Ionomer Sealant (test) and Oral hygiene orientation and professional fluoride application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Dec 2018
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- They will be included in this study children:
- aged 3 years and 6 years and 11 months;
- With complete primary dentition;
- Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.
- Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.
Who cannot join
- who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;
- who are involved in other research that may impact on this study;
- whose parents that not agree in participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial
This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.
Read the detailed description
This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.
- Conditions
- Dental Caries
- Being tested
- Ionomer Restoration (control), Ionomer Sealant (test), Oral hygiene orientation and professional fluoride application
- Keywords
- Dental Caries, Primary tooth, Ionomer Sealants, Glass Ionomer Restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ionomer Restoration (control)Procedure or surgery
Also called glass ionomer cement, restoration
Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements
Ionomer Sealant (test)Procedure or surgery
Also called glass ionomer cement, sealant
Sealing of moderate caries lesions without any caries removal or cavity opening.
Oral hygiene orientation and professional fluoride applicationProcedure or surgery
Oral hygiene orientation and professional fluoride application
| Study group | Role | What they receive |
|---|---|---|
| restoration - control | Active comparator | Restoration Receives: Procedure: Ionomer Restoration (control); Procedure: Oral hygiene orientation and professional fluoride application |
| sealant - test | Experimental | Sealant Receives: Procedure: Ionomer Sealant (test); Procedure: Oral hygiene orientation and professional fluoride application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of reintervention
Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline.
After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.
Measured: 24 months
Secondary outcomes (2)
Child's reported discomfort
The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale
Measured: 1st day
Duration of treatments
Time spent in interventions will be recorded.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005405
- Sponsor's protocol ID
- SEALANT-CARDEC02
- Status last verified
- Mar 2018
- First submitted
- 17 Aug 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication of all results, accessibility to data if necessary
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03005405
- Acronym / sponsor ID
- SEALANT-CARDEC02
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Primary tooth, Ionomer Sealants, Glass Ionomer Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- 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 protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.
Detailed description
This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restoration - control | Active comparator | Procedure: Ionomer Restoration (control), Procedure: Oral hygiene orientation and professional fluoride applicationRestoration |
| sealant - test | Experimental | Procedure: Ionomer Sealant (test), Procedure: Oral hygiene orientation and professional fluoride applicationSealant |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- aged 3 years and 6 years and 11 months;
- With complete primary dentition;
- Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.
- Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.
Key exclusion criteria (3 listed)
- who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;
- who are involved in other research that may impact on this study;
- whose parents that not agree in participate.
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 |
|---|---|---|
| Ionomer Restoration (control)Also: glass ionomer cement, restorationRestoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements | Procedure or surgery | restoration - control |
| Ionomer Sealant (test)Also: glass ionomer cement, sealantSealing of moderate caries lesions without any caries removal or cavity opening. | Procedure or surgery | sealant - test |
| Oral hygiene orientation and professional fluoride applicationOral hygiene orientation and professional fluoride application | Procedure or surgery | restoration - control, sealant - test |
Primary outcome
Need of reintervention
Time frame: 24 months
Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline. After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.
2 secondary outcomes
Child's reported discomfort
Time frame: 1st day
Duration of treatments
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Yes. Publication of all results, accessibility to data if necessary
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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.
Mariana M Braga, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ionomer Sealant (test) and Oral hygiene orientation and professional fluoride application in people with Dental Caries, run by University of Sao Paulo 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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?
Need of reintervention (time frame: 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 22 Mar 2018.