Dental Caries in ChildrenNCT04127357
Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
A study testing 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). in people with Dental Caries in Children and Pit and Fissure Sealant, run by Faculty Sao Leopoldo Mandic Campinas.
Trial summary
Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Pit and Fissure Sealant, Toothbrushing
- What is being tested?
- 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2015to 12 Aug 2019
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one primary molar with active caries lesions classified as ICDAS score 3.
Who cannot join
- Children with differentiated management needs and/or systemic diseases with oral involvement.
- Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.
About this study
Official title: Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial
Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.
- Being tested
- 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
- Keywords
- Pit and fissure sealants, Pediatric dentistry, Toothbrushing
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).Procedure or surgery
After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil).
The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months.
| Study group | Role | What they receive |
|---|---|---|
| A - Control | Other | Brushing with 1450 ppm fluoride toothpaste. Receives: Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). |
| B - Test | Experimental | Resin sealing (FluroShield, Dentsply, Brazil). Receives: Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of caries progression
With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.
Measured: 6 months
Clinical evaluation of caries progression
With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.
Measured: 12 months
Secondary outcomes (2)
Sealant retention
Clinical evaluation of sealant retention was performed using the criteria used by Pardi: RT- total retention, PP1- presence of sealant on two thirds of the occlusal surface, PP2- presence of sealant on one third of the occlusal surface. PT-total loss of sealant on occlusal surface.
Measured: 6 months
Sealant retention
Clinical evaluation of sealant retention was performed using the criteria used by Pardi: RT- total retention, PP1- presence of sealant on two thirds of the occlusal surface, PP2- presence of sealant on one third of the occlusal surface. PT-total loss of sealant on occlusal surface.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start5 Mar 2015
- Primary completion1 Sep 2016
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
- Investigators
- Jose Carlos P Imparato, PhD, Principal investigator, Sao Leopoldo Mandic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127357
- Sponsor's protocol ID
- SLM 8
- Status last verified
- Oct 2019
- First submitted
- 12 Aug 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meyer-Lueckel H, Paris S. When and How to Intervene in the Caries Process. Oper Dent. 2016 Sep;41(S7):S35-S47. doi: 10.2341/15-022-O.
PubMed 27689929Bakhshandeh A, Qvist V, Ekstrand KR. Sealing occlusal caries lesions in adults referred for restorative treatment: 2-3 years of follow-up. Clin Oral Investig. 2012 Apr;16(2):521-9. doi: 10.1007/s00784-011-0549-4. Epub 2011 Apr 9.
PubMed 21479565
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial
- ClinicalTrials.gov ID
- NCT04127357
- Acronym / sponsor ID
- SLM 8
- Keywords
- Pit and fissure sealants, Pediatric dentistry, Toothbrushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 15 Oct 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.
Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Control | Other | Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).Brushing with 1450 ppm fluoride toothpaste. |
| B - Test | Experimental | Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).Resin sealing (FluroShield, Dentsply, Brazil). |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- At least one primary molar with active caries lesions classified as ICDAS score 3.
Key exclusion criteria (2 listed)
- Children with differentiated management needs and/or systemic diseases with oral involvement.
- Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.
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 |
|---|---|---|
| 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil). The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months. | Procedure or surgery | A - Control, B - Test |
Primary outcome
Clinical evaluation of caries progression
Time frame: 6 months
With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.
Clinical evaluation of caries progression
Time frame: 12 months
With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.
2 secondary outcomes
Sealant retention
Time frame: 6 months
Sealant retention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Results publication: PubMed 27689929Meyer-Lueckel H, Paris S. When and How to Intervene in the Caries Process. Oper Dent. 2016 Sep;41(S7):S35-S47. doi: 10.2341/15-022-O.
- Results publication: PubMed 21479565Bakhshandeh A, Qvist V, Ekstrand KR. Sealing occlusal caries lesions in adults referred for restorative treatment: 2-3 years of follow-up. Clin Oral Investig. 2012 Apr;16(2):521-9. doi: 10.1007/s00784-011-0549-4. Epub 2011 Apr 9.
- 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. This study is not recruiting at the moment.
Jose Carlos P Imparato, PhD principal investigator
Sao Leopoldo Mandic
Questions about this trial
What is this clinical trial studying?
A study testing 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil). in people with Dental Caries in Children and Pit and Fissure Sealant, run by Faculty Sao Leopoldo Mandic Campinas.
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 2 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: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical evaluation of caries progression (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04127357, which also lists 2 linked publications.
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 Oct 2019.