RBR-3bbwwjz Clinical performance of two glass ionomer cements used as restorative materials in Atraumatic Restorative Treatment (den...

Date of registration: 07/24/2023 ^(mm/dd/yyyy)
Last approval date : 07/24/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1289-3110

• Public title:

  en

  Clinical performance of two glass ionomer cements used as restorative materials in Atraumatic Restorative Treatment (dental restorations)

  pt-br

  Desempenho clínico de dois cimentos de ionômero de vidro utilizados como materiais restauradores em Tratamento Restaurador Atraumático (restaurações dentárias)

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 06809312.1.0000.5054
    Issuing authority: Plataforma Brasil
  • 277.695
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Ceará/PROPESQ

Sponsors

• Primary sponsor: Universidade Federal do Ceará
• Secondary sponsor:
  • Institution: Universidade Federal do Ceará
• Supporting source:
  • Institution: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Health conditions

• Health conditions:

  en

  Dental Caries

  pt-br

  Cárie Dentária

• General descriptors for health conditions:

  en

  C07 Stomatognathic Diseases

  pt-br

  C07 Doenças Estomatognáticas

• Specific descriptors:

  en

  C07.793.720.210 Dental Caries

  pt-br

  C07.793.720.210 Cárie Dentária

Interventions

• Interventions:

  en

  After initial clinical evaluation, a total of 34 participants aged 10 to 15 years with at least one of the upper and/or lower permanent molars with cavitated dentin occlusal caries lesion were selected. Fifty-six teeth were randomly allocated into two intervention groups for ART restorations: control (27 teeth restored with Ketac Molar Easy Mix glass ionomer cement) and experimental (29 teeth restored with Vitro Molar glass ionomer cement). The randomization process was conducted using opaque and sealed envelopes, containing the randomized numbers assigned to each intervention group. The envelope was opened by the dental assistant who handled the glass ionomer cement to the operator only after complete preparation. The operator was not completely blinded to the restorative material, because of differences in the consistency of the materials. Participants were blinded to the intervention group. All restorations were performed according to the principles of Atraumatic Restorative Treatment (ART). Treatments were performed at baseline and reassessed at 6, 12, and 48 months. This was a double-blind (participants and evaluators) randomized controlled trial.

  pt-br

  Após avaliação clínica inicial, foi selecionado um total de 34 participantes de 10 a 15 anos de idade com pelo menos um dos molares permanentes superiores e/ou inferiores com lesão de cárie oclusal dentinária cavitada. Foram selecionados 56 dentes que foram alocados aleatoriamente em dois grupos de intervenção para as restaurações ART: controle (27 dentes restaurados com o cimento de ionômero de vidro Ketac Molar Easy Mix) e experimental (29 dentes restaurados com cimento de ionômero de vidro Vitro Molar). O processo de randomização foi realizado por meio de envelopes opacos e lacrados, contendo os números randomizados atribuídos a cada grupo de intervenção. O envelope foi aberto pela auxiliar de dentista que entregou o cimento de ionômero de vidro à operadora somente após o preparo completo. O operador não estava completamente cego para o material restaurador, por causa das diferenças na consistência dos materiais. Os participantes eram cegos para o grupo de intervenção. Todas as restaurações foram realizadas de acordo com os princípios do Tratamento Restaurador Atraumático (ART). Os tratamentos foram realizados no início do estudo e reavaliados no período de 6, 12 e 48 meses. Este foi um estudo randomizado controlado duplo-cego (participantes e avaliadores).

• Descriptors:

  en

  E06.070 Dental Atraumatic Restorative Treatment

  pt-br

  E06.070 Tratamento Dentário Restaurador sem Trauma

  en

  D25.339.291.402 Glass Ionomer Cements

  pt-br

  D25.339.291.402 Cimentos de Ionômeros de Vidro

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 06/10/2013 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  34	-	10 Y	15 Y

• Inclusion criteria:

  en

  Children and adolescents in good general health; aged between 10 and 15 years; both sexes; residents of the municipality of Sobral; present a collaborative behavior to carry out the clinical procedure; present at least one of the upper and/or lower permanent molars with cavitated dentin occlusal caries lesion accessible to manual instruments with a minimum opening of 0.9 mm; present the Informed Consent Term signed by the parents/guardians

  pt-br

  Crianças e adolescentes com boa saúde geral; com idade entre 10 e 15 anos; ambos os sexos; residentes do município de Sobral; apresentar um comportamento colaborador para realização do procedimento clínico; apresentar pelo menos um dos molares permanentes superiores e/ou inferiores com lesão de cárie oclusal dentinária cavitada acessível a instrumentos manuais com abertura mínima de 0,9 mm; apresentar o Termo de Consentimento Livre e Esclarecido assinado pelos pais/responsáveis

• Exclusion criteria:

  en

  Permanent molars with pulp exposure; fistula; abscess; pathological mobility; spontaneous pain; carious dentin lesion not accessible to hand instruments

  pt-br

  Molares permanentes com presença de exposição pulpar; fístula; abscesso; mobilidade patológica; dor espontânea; lesão cariosa de dentina não acessível a instrumentos manuais

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Outcome expected 1: To evaluate the performance and clinical longevity of ART restorations in occlusal cavities of permanent molars with two different glass ionomer cements(Ketac Molar Easy Mix and Vitro Molar). The restorations were evaluated after 6, 12 and 48 months according to ART (Atraumatic Restorative Treatment) and USPHS (United States Public Health Service) criteria.

  pt-br

  Desfecho esperado 1: Avaliar o desempenho e longevidade clínica de restaurações ART em cavidades oclusais de molares permanentes com dois diferentes cimentos de ionômero de vidro (Ketac Molar Easy Mix e Vitro Molar). As restaurações foram avaliadas após 6, 12 e 48 meses de acordo com os critérios do ART (Tratamento Restaurador Atraumático) e do USPHS (United States Public Health Service).

  en

  Outcome found 1: There was no significant difference in relation to the clinical performance of ART restorations performed with the different glass ionomer cements tested, when compared to each other and when evaluated in the different study periods.

  pt-br

  Desfecho encontrado 1: Não houve diferença significativa em relação ao desempenho clínico das restaurações de ART realizadas com os diferentes cimentos de ionômero de vidro testados, quando comparadas entre si e quando avaliadas nos diferentes períodos de estudo.

• Secondary outcomes:

  en

  No secondary outcomes expected

  pt-br

  Não são esperados desfechos secundários

Summary Results

• Url link for results: não se aplica

• Baseline char:

  en

  A total of 34 participants were selected to participate in this study. The age range of participating children and adolescents was between 10 and 15 years old. All participants came from the city of Sobral, Ceará, Brazil. The research was carried out in two municipal public schools in the city of Sobral, Ceará.
  Fifty-six restorations were performed according to the atraumatic restorative treatment (ART) on the occlusal surface of permanent molars in children and adolescents. The teeth selected for the study were randomly divided into two groups, in which Ketac Molar Easy Mix (3M ESPE Dental AG, Seefeld, Germany) (n=27) and Vitro Molar (DFL Indústria e Comércio Ltda, Rio de Janeiro, Germany) restorative materials were used. de Janeiro, RJ, Brazil) (n=29). The restorations were evaluated at 6 months, 12 months and 48 months after the restorative procedure using the evaluation criteria used (ART and USPHS).

• Participants flow:

  en

  The sample of this study was for convenience of this study. The participants were from two municipal public schools in the city of Sobral, Ceará, Brazil. Dental clinical examination was carried out in 180 children and adolescents to carry out the selection of study participants. A total of 146 children/adolescents were excluded for not meeting the inclusion criteria of the study. Therefore, 34 children/adolescents participated in this study.

• Adverse events:

  en

  There were no adverse events to the study.

• Outcome measure:

  en

  To compare the different evaluation criteria of the same material over time, McNemar's non-parametric test was used. To compare the criteria between the different materials, in the different periods evaluated, the chi-square test was used. In all analyses, a significance level of 5% (p<0.05) was considered. The analysis was performed using GraphPad Prism 6.0 software.
  
  After the periods of 6 months and 12 months, evaluations of all restorations were carried out, thus constituting a return rate of 100%. After a period of 48 months, 50 restorations were evaluated (25 restorations performed with Ketac Molar Easy Mix and 25 with Vitro Molar restorative material). There was a loss of sample in the evaluation at 48 months due to the impossibility of locating some research participants.
  
  According to the ART criterion for evaluation of restorations, the success percentages of restorations performed with Ketac Molar Easy Mix were 96%, 85% and 80% referring to the evaluation periods of 6 months, 12 months and 48 months, respectively.
  As for the Vitro Molar restorative material, the success percentages of the restorations performed with this material were 100%, 89% and 76% referring to the evaluation periods of 6 months, 12 months and 48 months, respectively.
  According to the evaluation criteria used (ART and USPHS) there was no statistical difference in relation to the clinical performance of the two analyzed materials, when compared to each other and when evaluated in different study periods (p>0.05).

• Results summary:

  en

  Introduction: Atraumatic Restorative Treatment (ART) is a minimally invasive technique that uses hand instruments to remove compromised dentin and enamel to stop the progression of caries. Properties such as mechanical strength, adhesion to the tooth structure, biocompatibility and fluoride release justify the indication of glass ionomer cements as the most suitable restorative materials for the technique.
  Objective: The aim of the present study was to evaluate the clinical performance of Atraumatic Restorative Treatment (ART) restorations performed with two different glass ionomer cements (GIC) in permanent molars for a follow-up period of 48 months.
  Methodology: Fifty-six occlusal class I restorations were performed on permanent molars of 34 children and adolescents aged between 10 and 15 years in two municipal schools in the city of Sobral, Ceará, Brazil. The evaluated materials were Ketac Molar Easy Mix (3M ESPE Dental AG, Seefeld, Germany) and Vitro Molar (DFL Indústria e Comércio Ltda, Rio de Janeiro, RJ, Brazil). The restorations were evaluated at 6 months, 12 months and 48 months after the restorative procedure according to the ART and USPHS evaluation criteria.
  Results: According to the ART criteria, the success percentages of restorations performed with Ketac Molar Easy Mix (n=27) were 96%, 85% and 80% referring to the evaluation periods of 6 months, 12 months and 48 months , respectively. As for the restorative material Vitro Molar, the percentages of success of the restorations performed with this material (n=29) were 100%, 89% and 76% referring to the evaluation periods of 6 months, 12 months and 48 months, respectively. There was no statistical difference in relation to the clinical performance of the two analyzed materials, when compared to each other and when evaluated in different study periods (p>0.05).
  Conclusion: Both GIC showed satisfactory clinical performance in single-surface occlusal restorations on permanent molars after 48 months.

Data Sharing Plan

• Data Sharing Plan:

  en

  No

Contacts

• Public contact
  • Full name: Mário Áureo Gomes Moreira
  • • Address: Rua Conselheiro José Júlio Sn/N
    • City: Sobral / Brazil
    • Zip code: 62.010-820
  • Phone: +55 88 3695-4622
  • Email: mario@sobral.ufc.br
  • Affiliation: Universidade Federal do Ceará
   
• Scientific contact
  • Full name: Mário Áureo Gomes Moreira
  • • Address: Rua Conselheiro José Júlio Sn/N
    • City: Sobral / Brazil
    • Zip code: 62.010-820
  • Phone: +55 88 3695-4622
  • Email: mario@sobral.ufc.br
  • Affiliation: Universidade Federal do Ceará
   
• Site contact
  • Full name: Mário Áureo Gomes Moreira
  • • Address: Rua Conselheiro José Júlio Sn/N
    • City: Sobral / Brazil
    • Zip code: 62.010-820
  • Phone: +55 88 3695-4622
  • Email: mario@sobral.ufc.br
  • Affiliation: Universidade Federal do Ceará
   

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