Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children

NCT02617940 | Completed

• 1 other identifier: SLM1
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

dental caries; primary tooth; resin-based sealants

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Every 6 months up to 12 months

Secondary Outcomes (5)

• Sealants and oral hygiene orientation costs

  Baseline

• Sealants cost-efficacy

  Through study completion (12 months)

• Impact on children's quality of life of sealants or oral hygiene orientation

  6 and 12 months

• Children self-reported discomfort

  Baseline

• Parents' reported satisfaction with treatment

  6 months

Study Arms (2)

fissure sealant

EXPERIMENTAL

single placement of resin-based sealant on occlusal surface and oral hygiene orientation

Other: fissure sealant

oral hygiene orientation

PLACEBO COMPARATOR

single application of water on occlusal surface and oral hygiene orientation

Other: oral hygiene orientation

Interventions

fissure sealant OTHER

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).

fissure sealant

oral hygiene orientation OTHER

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.

oral hygiene orientation

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty Sao Leopoldo Mandic Campinas: lead

Study Sites (1)

Jose Carlos Pettorossi Imparato

São Paulo, 05508000, Brazil

Location

Related Publications (16)

• 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.

  PMID: 24296163 BACKGROUND

• 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.

  PMID: 23543512 BACKGROUND

• 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.

  PMID: 25674325 BACKGROUND

• 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.

  PMID: 17284913 BACKGROUND

• 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.

  PMID: 26116491 BACKGROUND

• 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.

  PMID: 25710951 BACKGROUND

• 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.

  PMID: 20091655 BACKGROUND

• 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.

  PMID: 25923059 BACKGROUND

• 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.

  PMID: 22736448 BACKGROUND

• Mendes FM, Braga MM. Caries detection in primary teeth is less challenging than in permanent teeth. Dent Hypotheses 4: 17-20, 2013.

  BACKGROUND

• 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.

  PMID: 23257929 BACKGROUND

• 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.

  PMID: 21808914 BACKGROUND

• 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.

  PMID: 11291631 BACKGROUND

• 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.

  PMID: 15719917 BACKGROUND

• 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.

  PMID: 17518963 BACKGROUND

• 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.

  PMID: 9165195 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jose CP Imparato, PhD

  Faculty Sao Leopoldo Mandic Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: December 1, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

BR (1)