Fissure SealantsSLM1661NCT02617940
Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children
A study testing fissure sealant and oral hygiene orientation in people with Fissure Sealants and Oral Hygiene Orientation, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Fissure Sealants, Oral Hygiene Orientation
- What is being tested?
- fissure sealant and oral hygiene orientation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Dec 2016
- 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
- No healthy volunteers
- Child
Who may be able to join
- parents or legal guardians accept and sign the informed consent form.
- children must have at least one molar with caries lesion classified as ICDAS active score 3.
Who cannot join
- children with special needs and/or systemic diseases with oral impairment.
- teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin or other types of formation defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children
The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. The costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. Poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. This test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. Time, costs and impact on quality of life of the treatments will be compared by Student's t test. For all analyses, the significance level will be set at 5%.
- Conditions
- Fissure Sealants, Oral Hygiene Orientation
- Being tested
- fissure sealant, oral hygiene orientation
- Keywords
- dental caries, primary tooth, resin-based sealants
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fissure sealantOther
Surfaces allocated to this group will be treated with resin-based sealant (FluroShield®, Dentsply, United States of America) according to the manufacturer's instructions.
Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. The sealant will be dispensed on the occlusal surface and light cured for 20 seconds (Optilight Max, Gnatus, Brazil).
oral hygiene orientationOther
Surfaces allocated to this group will be treated with sterile water application, as a placebo, without anesthesia and rubber dam. The active treatment in this group will be only oral hygiene orientations.
| Study group | Role | What they receive |
|---|---|---|
| fissure sealant | Experimental | single placement of resin-based sealant on occlusal surface and oral hygiene orientation Receives: Other: fissure sealant |
| oral hygiene orientation | Placebo comparator | single application of water on occlusal surface and oral hygiene orientation Receives: Other: oral hygiene orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealants clinical efficacy
The clinical evaluation will be performed by one blinded examiner. If the surface is sealed, the examiner will classify it according to described by Pardi et al. (2005); if the surface is without material, the examiner will use the International Caries Detection and Assessment System (ICDAS) criteria (Ismail et al., 2007).
Measured: Every 6 months up to 12 months
Sealants radiographic efficacy
The radiographic evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiograph using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, United States of America) in order to make the radiographic subtraction.
Measured: Every 6 months up to 12 months
Secondary outcomes (5)
Sealants and oral hygiene orientation costs
Treatment costs will be calculated for each treatment technique considering professional costs and procedure costs. In order to calculate the professional cost, the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment. To estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), we will consider their price, the lifespan of five years and a monthly use of 160 hours, resulting in an estimate value per hour. All materials used in each procedure will have their quantity registered. Prices will be inferences from the market value converted in US Dollars.
Measured: Baseline
Sealants cost-efficacy
The costs of each treatment procedure will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
Measured: Through study completion (12 months)
Impact on children's quality of life of sealants or oral hygiene orientation
The oral health related to quality of life will be measured using a validated questionnaire according to the children's age. The Early Childhood Oral Health Impact Scale (ECOHIS) will be applied with 4-5 years old children and Child Perceptions Questionnaire will be used for 6-9 (CPQ8-10) years old children. They will be applied immediately before the procedure and on 6 months follow-up
Measured: 6 and 12 months
Children self-reported discomfort
The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interferences.
Measured: Baseline
Parents' reported satisfaction with treatment
The parents'/guardians' satisfaction with treatment will be evaluated using a questionnaire. It will be applied only at the 6-months follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Fissure SealantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 546 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 CP Imparato, PhD, Principal investigator, Faculty Sao Leopoldo Mandic Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617940
- Sponsor's protocol ID
- SLM1
- Acronym
- SLM1661
- Status last verified
- May 2017
- First submitted
- 22 Nov 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Erdemir U, Sancakli HS, Yaman BC, Ozel S, Yucel T, Yildiz E. Clinical comparison of a flowable composite and fissure sealant: a 24-month split-mouth, randomized, and controlled study. J Dent. 2014 Feb;42(2):149-57. doi: 10.1016/j.jdent.2013.11.015. Epub 2013 Dec 1.
PubMed 24296163Ahovuo-Saloranta A, Forss H, Walsh T, Hiiri A, Nordblad A, Makela M, Worthington HV. Sealants for preventing dental decay in the permanent teeth. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD001830. doi: 10.1002/14651858.CD001830.pub4.
PubMed 23543512Morales-Chavez MC, Nualart-Grollmus ZC. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant in children with special needs. J Clin Exp Dent. 2014 Dec 1;6(5):e551-5. doi: 10.4317/jced.51688. eCollection 2014 Dec.
PubMed 25674325Ricketts DN, Ekstrand KR, Martignon S, Ellwood R, Alatsaris M, Nugent Z. Accuracy and reproducibility of conventional radiographic assessment and subtraction radiography in detecting demineralization in occlusal surfaces. Caries Res. 2007;41(2):121-8. doi: 10.1159/000098045.
PubMed 17284913Hilgert LA, Leal SC, Mulder J, Creugers NH, Frencken JE. Caries-preventive Effect of Supervised Toothbrushing and Sealants. J Dent Res. 2015 Sep;94(9):1218-24. doi: 10.1177/0022034515592857. Epub 2015 Jun 26.
PubMed 26116491Schwendicke F, Jager AM, Paris S, Hsu LY, Tu YK. Treating pit-and-fissure caries: a systematic review and network meta-analysis. J Dent Res. 2015 Apr;94(4):522-33. doi: 10.1177/0022034515571184. Epub 2015 Feb 20.
PubMed 25710951Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.
PubMed 20091655Guedes RS, Piovesan C, Floriano I, Emmanuelli B, Braga MM, Ekstrand KR, Ardenghi TM, Mendes FM. Risk of initial and moderate caries lesions in primary teeth to progress to dentine cavitation: a 2-year cohort study. Int J Paediatr Dent. 2016 Mar;26(2):116-24. doi: 10.1111/ipd.12166. Epub 2015 Apr 28.
PubMed 25923059Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
PubMed 22736448Mendes FM, Braga MM. Caries detection in primary teeth is less challenging than in permanent teeth. Dent Hypotheses 4: 17-20, 2013.
Martins-Junior PA, Vieira-Andrade RG, Correa-Faria P, Oliveira-Ferreira F, Marques LS, Ramos-Jorge ML. Impact of early childhood caries on the oral health-related quality of life of preschool children and their parents. Caries Res. 2013;47(3):211-8. doi: 10.1159/000345534. Epub 2012 Dec 13.
PubMed 23257929Barbosa Tde S, Gaviao MB. [Quality of life and oral health in children - Part II: Brazilian version of the Child Perceptions Questionnaire]. Cien Saude Colet. 2011 Jul;16(7):3267-76. doi: 10.1590/s1413-81232011000800026. Portuguese.
PubMed 21808914Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.
PubMed 11291631Pardi V, Pereira AC, Ambrosano GM, Meneghim Mde C. Clinical evaluation of three different materials used as pit and fissure sealant: 24-months results. J Clin Pediatr Dent. 2005 Winter;29(2):133-7. doi: 10.17796/jcpd.29.2.e44h17387x324345.
PubMed 15719917Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children
- ClinicalTrials.gov ID
- NCT02617940
- Acronym / sponsor ID
- SLM1661 / SLM1
- Conditions
- Fissure Sealants, Oral Hygiene Orientation
- Keywords
- dental caries, primary tooth, resin-based sealants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Dec 2015 (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.
The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. The costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. Poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. This test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. Time, costs and impact on quality of life of the treatments will be compared by Student's t test. For all analyses, the significance level will be set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fissure sealant | Experimental | Other: fissure sealantsingle placement of resin-based sealant on occlusal surface and oral hygiene orientation |
| oral hygiene orientation | Placebo comparator | Other: oral hygiene orientationsingle application of water on occlusal surface and oral hygiene orientation |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- parents or legal guardians accept and sign the informed consent form.
- children must have at least one molar with caries lesion classified as ICDAS active score 3.
Key exclusion criteria (2 listed)
- children with special needs and/or systemic diseases with oral impairment.
- teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin 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 |
|---|---|---|
| fissure sealantSurfaces allocated to this group will be treated with resin-based sealant (FluroShield®, Dentsply, United States of America) according to the manufacturer's instructions. Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. The sealant will be dispensed on the occlusal surface and light cured for 20 seconds (Optilight Max, Gnatus, Brazil). | Other | fissure sealant |
| oral hygiene orientationSurfaces allocated to this group will be treated with sterile water application, as a placebo, without anesthesia and rubber dam. The active treatment in this group will be only oral hygiene orientations. | Other | oral hygiene orientation |
Primary outcome
Sealants clinical efficacy
Time frame: Every 6 months up to 12 months
The clinical evaluation will be performed by one blinded examiner. If the surface is sealed, the examiner will classify it according to described by Pardi et al. (2005); if the surface is without material, the examiner will use the International Caries Detection and Assessment System (ICDAS) criteria (Ismail et al., 2007).
Sealants radiographic efficacy
Time frame: Every 6 months up to 12 months
The radiographic evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiograph using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, United States of America) in order to make the radiographic subtraction.
5 secondary outcomes
Sealants and oral hygiene orientation costs
Time frame: Baseline
Sealants cost-efficacy
Time frame: Through study completion (12 months)
Impact on children's quality of life of sealants or oral hygiene orientation
Time frame: 6 and 12 months
Children self-reported discomfort
Time frame: Baseline
Parents' reported satisfaction with treatment
Time frame: 6 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 5 May 2017.
- Background: PubMed 24296163Erdemir U, Sancakli HS, Yaman BC, Ozel S, Yucel T, Yildiz E. Clinical comparison of a flowable composite and fissure sealant: a 24-month split-mouth, randomized, and controlled study. J Dent. 2014 Feb;42(2):149-57. doi: 10.1016/j.jdent.2013.11.015. Epub 2013 Dec 1.
- Background: PubMed 23543512Ahovuo-Saloranta A, Forss H, Walsh T, Hiiri A, Nordblad A, Makela M, Worthington HV. Sealants for preventing dental decay in the permanent teeth. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD001830. doi: 10.1002/14651858.CD001830.pub4.
- Background: PubMed 25674325Morales-Chavez MC, Nualart-Grollmus ZC. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant in children with special needs. J Clin Exp Dent. 2014 Dec 1;6(5):e551-5. doi: 10.4317/jced.51688. eCollection 2014 Dec.
- Background: PubMed 17284913Ricketts DN, Ekstrand KR, Martignon S, Ellwood R, Alatsaris M, Nugent Z. Accuracy and reproducibility of conventional radiographic assessment and subtraction radiography in detecting demineralization in occlusal surfaces. Caries Res. 2007;41(2):121-8. doi: 10.1159/000098045.
- Background: PubMed 26116491Hilgert LA, Leal SC, Mulder J, Creugers NH, Frencken JE. Caries-preventive Effect of Supervised Toothbrushing and Sealants. J Dent Res. 2015 Sep;94(9):1218-24. doi: 10.1177/0022034515592857. Epub 2015 Jun 26.
- Background: PubMed 25710951Schwendicke F, Jager AM, Paris S, Hsu LY, Tu YK. Treating pit-and-fissure caries: a systematic review and network meta-analysis. J Dent Res. 2015 Apr;94(4):522-33. doi: 10.1177/0022034515571184. Epub 2015 Feb 20.
- Background: PubMed 20091655Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.
- Background: PubMed 25923059Guedes RS, Piovesan C, Floriano I, Emmanuelli B, Braga MM, Ekstrand KR, Ardenghi TM, Mendes FM. Risk of initial and moderate caries lesions in primary teeth to progress to dentine cavitation: a 2-year cohort study. Int J Paediatr Dent. 2016 Mar;26(2):116-24. doi: 10.1111/ipd.12166. Epub 2015 Apr 28.
- Background: PubMed 22736448Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
- BackgroundMendes FM, Braga MM. Caries detection in primary teeth is less challenging than in permanent teeth. Dent Hypotheses 4: 17-20, 2013.
- Background: PubMed 23257929Martins-Junior PA, Vieira-Andrade RG, Correa-Faria P, Oliveira-Ferreira F, Marques LS, Ramos-Jorge ML. Impact of early childhood caries on the oral health-related quality of life of preschool children and their parents. Caries Res. 2013;47(3):211-8. doi: 10.1159/000345534. Epub 2012 Dec 13.
- Background: PubMed 21808914Barbosa Tde S, Gaviao MB. [Quality of life and oral health in children - Part II: Brazilian version of the Child Perceptions Questionnaire]. Cien Saude Colet. 2011 Jul;16(7):3267-76. doi: 10.1590/s1413-81232011000800026. Portuguese.
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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 CP Imparato, PhD principal investigator
Faculty Sao Leopoldo Mandic Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fissure sealant and oral hygiene orientation in people with Fissure Sealants and Oral Hygiene Orientation, run by Faculty Sao Leopoldo Mandic Campinas 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 2 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 5 May 2017. 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. Some participants in this study may receive a placebo. 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?
Sealants clinical efficacy (time frame: Every 6 months up to 12 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 NCT02617940, which also lists 16 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 5 May 2017.