Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
19 de noviembre de 2021 actualizado por: Alshimaa Nasser Mahmoud
clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Hypothesis: Could the preheated composite affect the temperature of the pulpal floor
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
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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-
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Minya, Egipto, 61519
- Faculty of Dentistry - Minia University
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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
25 años a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy men and women patients of 25-45 years.
- They should have a good oral hygiene level.
- Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
- All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
- No preoperative pain.
- Normal occlusal contact with opposing teeth.
- No history of periodontal treatment, including periodontal surgery, in the past year.
- All patients had to sign a written consent before being included.
- A good likelihood of recall availability.
Exclusion Criteria:
- patient with severe periodontitis or severe erosion damage.
- patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
- patients reported bruxism or clenching.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non-restorable teeth or hopeless teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption.
- Alcoholic and smoker patients.
- Pregnant or breastfeeding ladies.
- Patients who had physical disabilities, or who are unable to brush their teeth.
- Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
- Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for a recall appointment.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Otros nombres:
|
|
Comparador activo: Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Otros nombres:
|
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Comparador activo: Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Otros nombres:
|
|
Comparador activo: Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
pulpal floor temperature and restoration temperature
Periodo de tiempo: one year
|
evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite All readings were taken with the presence of a rubber dam and recorded in Celsius (°C). Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device |
one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
Periodo de tiempo: one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
Periodo de tiempo: one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mona I Riad, Professor, Professor at Faculty of Dentistry Cairo University
- Director de estudio: Nermin A Mahmoud, Lecturer, Lecturer at Faculty of Dentistry Minia University
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)
1 de abril de 2021
Finalización primaria (Actual)
15 de junio de 2021
Finalización del estudio (Actual)
28 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
8 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
19 de noviembre de 2021
Publicado por primera vez (Actual)
1 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
19 de noviembre de 2021
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 490
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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
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