Public trial
RBR-889c9qv Evaluation of the heating of a bulk-fill thermoviscous composite resin in dental restoration
Date of registration: 10/04/2021 (mm/dd/yyyy)Last approval date : 10/04/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Clinical evaluation of different forms of heating in the performance of a Bulk-fill thermoviscous composite resin in the restoration of Non-carious cervical lesions
pt-br
Avaliação clínica de diferentes formas de aquecimento no desempenho de uma resina composta termoviscosa Bulk-fill em restauração de Lesões cervicais não-cariosas
es
Clinical evaluation of different forms of heating in the performance of a Bulk-fill thermoviscous composite resin in the restoration of Non-carious cervical lesions
Trial identification
- UTN code: U1111-1267-4473
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Public title:
en
Evaluation of the heating of a bulk-fill thermoviscous composite resin in dental restoration
pt-br
Avaliação do aquecimento de uma resina composta termoviscosa bulk-fill em restauração dental
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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47271121.6.0000.0105
Issuing authority: Plataforma Brasil
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4.742.223
Issuing authority: Plataforma Brasil
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47271121.6.0000.0105
Sponsors
- Primary sponsor: Universidade Estadual de Ponta Grossa
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Secondary sponsor:
- Institution: Universidade Estadual de Ponta Grossa
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Supporting source:
- Institution: Universidade Estadual de Ponta Grossa
Health conditions
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Health conditions:
en
Stomatognathic Diseases; Tooth Diseases
pt-br
Doenças Estomatognáticas; Doenças Dentárias
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General descriptors for health conditions:
en
C07 Stomatognathic Diseases
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C07 Doenças Estomatognáticas
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Specific descriptors:
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C07.793 Tooth Diseases
pt-br
C07.793 Doenças Dentárias
Interventions
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Interventions:
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CONTROL GROUP: 60 non-carious cervical lesions received application of a universal adhesive system (Futurabond U,Voco) applied in the self-etching mode associated with selective enamel conditioning; then they will be restored with thermoviscous bulk-fill composite based on nano-hybrid methacrylate (VisCalor bulk, Voco) will be placed in the Caps Dispenser (Caps Dispenser, Voco) and heated to 68° using a bench heater (Caps Waner, Voco) for 3 minutes. The restorative material will be inserted in a single increment (up to 4 mm) into the cavities, followed by light curing at an irradiance of 1200 mW/cm2 for 40s per increment. After filling the cavity, the restorations will be adjusted and polished with a sequence of sanding discs. EXPERIMENTAL GROUP: 60 non-carious cervical lesions received application of a universal adhesive system (Futurabond U,Voco) applied in the self-etching mode associated with selective enamel conditioning; then they will be restored with thermoviscous bulk-fill composite based on nano-hybrid methacrylate (VisCalor bulk, Voco) will be placed in the Caps dispenser/warmer (VisCalor Dispenser, Voco) and heated to 68° for 30 seconds. The restorative material will be inserted in a single increment (up to 4 mm) into the cavities, followed by light curing at an irradiance of 1200 mW/cm2 for 40s per increment. After filling the cavity, the restorations will be adjusted and polished with a sequence of sanding discs.
pt-br
GRUPO CONTROLE: 60 lesões cervicais não cariosas receberam aplicação de sistema adesivo universal (Futurabond U,Voco) aplicado no modo autocondicionante associado ao condicionamento seletivo do esmalte; após serão restauradas com compósito bulk-fill termoviscoso à base de metacrilato nano-hibrido (VisCalor bulk, Voco) será colocado no dispensador de Caps (Caps Dispenser, Voco) e aquecido a 68° utilizando um aquecedor de bancada (Caps Waner, Voco) durante 3 minutos. O material restaurador será inserido em incremento único (até 4 mm) nas cavidades, seguido por fotopolimerização a uma irradiância de 1200 mW/cm2 por 40s por incremento. Após o preenchimento da cavidade, as restaurações serão ajustadas e polidas com a sequências de discos de lixa. GRUPO EXPERIMENTAL: 60 lesões cervicais não cariosas receberam aplicação de sistema adesivo universal (Futurabond U,Voco) aplicado no modo autocondicionante associado ao condicionamento seletivo do esmalte; após serão restauradas com compósito bulk-fill termoviscoso à base de metacrilato nano-hibrido (VisCalor bulk, Voco) será colocado no dispensador/aquecedor de Caps (VisCalor Dispenser, Voco) e aquecido a 68° durante 30 segundos. O material restaurador será inserido em incremento único (até 4 mm) nas cavidades, seguido por fotopolimerização a uma irradiância de 1200 mW/cm2 por 40s por incremento. Após o preenchimento da cavidade, as restaurações serão ajustadas e polidas com a sequências de discos de lixa.
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Descriptors:
en
E06.323.428 Dental Restoration, Permanent
pt-br
E06.323.428 Restauração Dentária Permanente
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 06/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 120 - 18 Y 0 -
Inclusion criteria:
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Participants must be in good general health, be at least 18 years of age, have an acceptable level of oral hygiene, and have at least 20 teeth under occlusion. Entrants must have at least two comparable LCNCs (in size, shape and dimensions) to be restored. These lesions must be non-retentive, deeper than 0.5 mm, and involve both the enamel and dentin of vital teeth without mobility. The cavo-superficial margin cannot involve more than 50% of the enamel.
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Good general health, good oral hygiene and having at least 20 teeth under occlusion. Present at least two comparable NCLs (in size, shape and dimensions), non-retentive, deeper than 0.5 mm, and involving both enamel and dentin of vital teeth. The cavo-superficial margin cannot involve more than 50% of the enamel.
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Exclusion criteria:
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Extremely poor oral hygiene, using orthodontic devices, severe or chronic periodontitis, heavy bruxism habits. Known allergy to resin-based materials or any other material used in this study. Pregnant or lactating women, chronic use of anti-inflammatory, analgesic and psychotropic drugs.
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Higiene oral extremamente pobre, usando dispositivos ortodônticos, periodontite severa ou crônica, hábitos de bruxismo pesado. Alergia conhecida a materiais à base de resinas ou qualquer outro material usado neste estudo. Mulheres grávidas ou lactantes, uso crônico de drogas anti-inflamatórias, analgésicas e psicotrópicas.
Study type
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Study design:
en
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Cross-over 2 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
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Clinically evaluate the retention rate in the performance of different forms of heating (dispenser + bench heater vs. dispenser/heater) of a bulk-fill thermoviscous composite resin in LCNCs.
pt-br
Avaliar clinicamente a taxa de retenção no desempenho de diferentes formas de aquecimento (dispensador + aquecedor de bancada vs. dispensador/aquecedor) de uma resina composta termoviscosa bulk-fill em LCNCs.
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Secondary outcomes:
en
Clinically evaluate marginal discoloration, marginal adaptation, color matching, postoperative sensitivity, recurrent caries and biofilm retention on the performance of different forms of heating (dispenser + bench heater vs. dispenser/heater) of a bulk thermoviscous composite resin fill in LCNCs.
pt-br
Avaliar clinicamente a descoloração marginal, adaptação marginal, correspondência de cores, sensibilidade pós-operatória, cárie recorrente e retenção de biofilme no desempenho de diferentes formas de aquecimento (dispensador + aquecedor de bancada vs. dispensador/aquecedor) de uma resina composta termoviscosa bulk-fill em LCNCs.
Contacts
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Public contact
- Full name: Alessandro Dourado Loguercio
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- Address: Rua General Carlos Cavalcanti 4748
- City: Ponta Grossa / Brazil
- Zip code: 84030-900
- Phone: +55 (42) 3220 3740
- Email: aloguercio@hormail.com
- Affiliation:
- Full name: Michael Willian Favoreto
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- Address: Rua Carlos Cavalcanti, 4748 - Bloco M, Sala 64A - Uvaranas
- City: Ponta Grossa / Brazil
- Zip code: 84030-900
- Phone:
- Email: michaelfavoreto@hotmail.com
- Affiliation:
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Scientific contact
- Full name: Alessandro Dourado Loguercio
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- Address: Rua General Carlos Cavalcanti 4748
- City: Ponta Grossa / Brazil
- Zip code: 84030-900
- Phone: +55 (42) 3220 3740
- Email: aloguercio@hormail.com
- Affiliation:
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Site contact
- Full name: Alessandro Dourado Loguercio
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- Address: Rua General Carlos Cavalcanti 4748
- City: Ponta Grossa / Brazil
- Zip code: 84030-900
- Phone: +55 (42) 3220 3740
- Email: aloguercio@hormail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 11686.
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