Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children
NCT ID: NCT02617940
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
546 participants
INTERVENTIONAL
2015-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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fissure sealant
single placement of resin-based sealant on occlusal surface and oral hygiene orientation
fissure sealant
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 orientation
single application of water on occlusal surface and oral hygiene orientation
oral hygiene orientation
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.
Interventions
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fissure sealant
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 orientation
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.
Eligibility Criteria
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Inclusion Criteria
* children must have at least one molar with caries lesion classified as ICDAS active score 3.
Exclusion Criteria
* teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin or other types of formation defects.
4 Years
9 Years
ALL
No
Sponsors
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Faculty Sao Leopoldo Mandic Campinas
OTHER
Responsible Party
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Jose Carlos P Imparato
PhD, Senior Lecturer
Principal Investigators
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Jose CP Imparato, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty Sao Leopoldo Mandic Campinas
Locations
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Jose Carlos Pettorossi Imparato
São Paulo, , Brazil
Countries
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References
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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.
Ahovuo-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.
Morales-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.
Ricketts 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.
Hilgert 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.
Schwendicke 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.
Walsh 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.
Guedes 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.
Liu 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.
Mendes 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.
Barbosa 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.
Wong 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.
Pardi 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.
Ismail 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.
Ekstrand KR, Ricketts DN, Kidd EA. Reproducibility and accuracy of three methods for assessment of demineralization depth of the occlusal surface: an in vitro examination. Caries Res. 1997;31(3):224-31. doi: 10.1159/000262404.
Other Identifiers
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SLM1
Identifier Type: -
Identifier Source: org_study_id
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