Laser Etching Effect on Application Mode of Universal Adhesive
25 de marzo de 2021 actualizado 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
- Procedimiento: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
- Procedimiento: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
- Procedimiento: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
- Procedimiento: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
- Procedimiento: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
41
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ankara, Pavo, 06100
- Hacettepe University Faculty of Dentistry
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 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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Otro: 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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Otro: 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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Otro: 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Retention,
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: A. Ruya Yazici, Hacettepe University Faculty of Dentistry
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de julio de 2019
Finalización primaria (Actual)
10 de enero de 2021
Finalización del estudio (Anticipado)
25 de marzo de 2025
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
23 de marzo de 2021
Publicado por primera vez (Actual)
24 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
25 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KA180076
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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