Laser Etching Effect on Application Mode of Universal Adhesive
25 de março de 2021 atualizado por: A Ruya Yazici, Hacettepe University
Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
To evaluate the clinical performance of the restorations by applying the universal adhesive in different modes under the influence of different surface treatments, with Erbium Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser and acid etching in non-carious cervical lesions.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
- Procedimento: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
- Procedimento: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
- Procedimento: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
- Procedimento: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
- Procedimento: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Descrição detalhada
Forty-one patients (at least five non-carious cervical lesions) have participated in this study.
The non-carious cervical lesions in each patient were divided into five groups (total-etch mode with phosphoric acid, selective-etch mode with phosphoric acid, total-etch mode with laser, selective-etch mode with laser and self-etch mode) according to different modes and application methods of universal adhesive (Clearfil Universal Bond Quick, Kuraray).
Lesions were restored with a resin composite, Clearfil Majesty ES-2 (Kuraray).
All restorative procedures were performed by a single operator.
Restorations were evaluated at one week (baseline), at 6-, 12-, 18- and 24-month according to modified USPHS criteria (retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity, and secondary caries) by two experienced and calibrated investigators.
Tipo de estudo
Intervencional
Inscrição (Real)
41
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ankara, Peru, 06100
- Hacettepe University Faculty of Dentistry
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participants were 18 years of age or older,
- no possible health problems (such as allergies) related to resin-based restorations,
- good general health,
- having at least five non-carious cervical lesions.
- The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.
Exclusion Criteria
- Participant had fewer than 20 teeth,
- having poor oral hygiene,
- uncontrolled periodontal disease,
- xerostomia,
- pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,
- having bleaching treatment or orthodontic treatment.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Group I
Total-etch mode with 35% phosphoric acid
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35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s.
The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.
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Outro: Group II
Selective-etch mode with 35% phosphoric acid
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35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds.
Subsequently, the adhesive was applied in a similar manner to the TE-A group.
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Outro: Group III
Total-etch mode with laser (Er,Cr:YSGG)
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the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA).
Then the adhesive was applied in a similar manner to the TE-A group.
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Outro: Group IV
Selective-etch mode with laser (Er,Cr:YSGG)
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The laser system was applied in the same way as described in the TE-L group only on enamel surface.
Subsequently, the adhesive was applied in the same way as described in the TE-A group.
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Outro: Group V
Self-etch mode
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Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching.
Then gently air-dried for 5 s without waiting, and light-cured for 10 s.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Retention,
Prazo: From baseline to 2 year the change of restorations was evaluated
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The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent. |
From baseline to 2 year the change of restorations was evaluated
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Marginal Discoloration
Prazo: From baseline to 2 year the change of restorations was evaluated
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The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable. |
From baseline to 2 year the change of restorations was evaluated
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Marginal Adaptation
Prazo: From baseline to 2 year the change of restorations was evaluated
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Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable. |
From baseline to 2 year the change of restorations was evaluated
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Color match
Prazo: From baseline to 2 year the change of restorations was evaluated
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Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch. |
From baseline to 2 year the change of restorations was evaluated
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Post-op Hypersensitivity
Prazo: From baseline to 2 year the change of restorations was evaluated
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Determination of sensitivity after restorations are placed.
Alpha: Absent.
Charlie: Present; clinically unacceptable.
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From baseline to 2 year the change of restorations was evaluated
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Secondary Caries
Prazo: From baseline to 2 year the change of restorations was evaluated
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Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable. |
From baseline to 2 year the change of restorations was evaluated
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: A. Ruya Yazici, Hacettepe University Faculty of Dentistry
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Atalay C, Uslu A, Yazici AR. Does laser etching have an effect on application mode of a universal adhesive?-A microleakage and scanning electron microscopy evaluation. Microsc Res Tech. 2021 Jan;84(1):125-132. doi: 10.1002/jemt.23573. Epub 2020 Aug 27.
- Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020 Apr;24(4):1569-1578. doi: 10.1007/s00784-019-03052-2. Epub 2019 Aug 30.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de julho de 2019
Conclusão Primária (Real)
10 de janeiro de 2021
Conclusão do estudo (Antecipado)
25 de março de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
11 de março de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de março de 2021
Primeira postagem (Real)
24 de março de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de março de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- KA180076
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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produto fabricado e exportado dos EUA
Não
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