Aceite Esencial de Pelargonium Graveolens como Agente de Pulpotomía en Dientes Primarios
Evaluación Clínica y Radiográfica del Aceite Esencial de Pelargonium Graveolens como Agente de Pulpotomía en Dientes Primarios
The success of pulpotomy in primary teeth is critical for preserving function and arch integrity in children and depends largely on the biological properties of the medicament used. Given the limitations of mineral trioxide aggregate, Pelargonium graveolens essential oil has emerged as a potential alternative; however, its clinical performance as a pulpotomy agent remains insufficiently investigated.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The use of medicinal plants and herbal extracts in modern dentistry is steadily increasing, primarily due to their antimicrobial properties and high biocompatibility. Pelargonium graveolens (rose geranium), native to South Africa, produces an essential oil rich in geraniol, citronellol, and linalool[18]. Geraniol, present in rose geranium oil, is recognized for its antioxidant, anti-inflammatory, antimicrobial, and anticancer effects. The oil's main constituents, beta-citronellol and geraniol, contribute to its antifungal and wound-healing properties, making it a promising agent for treating denture-induced stomatitis
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: shaimaa eldesouky, assistant professor
- Número de teléfono: +201008994242
- Correo electrónico: shaimaaeldesouky@dent.tanta.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: nora Abo Shanady, lecturer
- Número de teléfono: 01091230999
- Correo electrónico: nora_aboshanady@dent.tanta.edu.eg
Ubicaciones de estudio
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Tanta, Egipto
- Aún no reclutando
- faculty of dentistry, Tanta university
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Contacto:
- shaimaa eldesouky, assistant professor
- Número de teléfono: 01008994242
- Correo electrónico: shaimaaeldesouky@dent.tanta.edu.eg
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Cairo Governorate
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Tanta, Cairo Governorate, Egipto, 31527
- Reclutamiento
- faculty of dentistry, Tanta university
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Contacto:
- shaimaa eldesouky, assistant professor
- Número de teléfono: 01008994242
- Correo electrónico: shaimaaeldesouky@dent.tanta.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Restorable primary molars with deep carious lesions.
- Absence of gingival swelling or sinus tract.
- Absence of spontaneous pain
- Absence of pain on percussion.
- Absence of discontinuity of lamina dura
- Absence of internal root resorption.
- Absence of external root resorption.
- Absence of inter-radicular or periapical bone destruction (radiolucency).
Exclusion Criteria:
- presence of spontaneous pain
- presence of gingival swelling or sinus tract
- presence of internal or external root resorption
- pain on percussion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: group 2: MTA
30 primary molars will be treated with MTA to cover pulp stumps |
Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software. Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown |
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Experimental: group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil paste
30 primary molars will be treated with geranium (Pelargonium graveolens) essential oil freshly mixed with zinc oxide powder till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps |
Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software. Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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absence of pain
Periodo de tiempo: up to 9 months
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Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain |
up to 9 months
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Tenderness to percussion
Periodo de tiempo: up to 9 months
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Measuring Method: Percussion test Measuring Unite: Binary (+/-) |
up to 9 months
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Furcation radiolucency
Periodo de tiempo: 3 months
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Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
3 months
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furcation radiolucency
Periodo de tiempo: 6 months
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Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
6 months
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furcation radiolucency
Periodo de tiempo: 9 months
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Description: Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
9 months
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absence of fistula
Periodo de tiempo: up to 9 months
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Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling |
up to 9 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: shimaa Hadwa, shimaa.hadwa@dent.tanta.edu.eg
Publicaciones y enlaces útiles
Publicaciones Generales
- Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
- Subramanyam, D. and S. Somasundaram, Clinical and radiographic outcome of herbal medicine versus standard pulpotomy medicaments in primary molars: a systematic review. J Clin Diagn Res, 2017. 11(10): p. ZE12-ZE16.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- # R-PED-12-25-3237
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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