- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07672470
Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary Molars
Modern Crown Options for Children: A Comparative Parent Satisfaction Study of Zirconia, Bioflx and 3D Printed Crown for Primary Molars.
This study will compare parent satisfaction with three different types of dental crowns used to restore primary (baby) molars in children: zirconia crowns, Bioflx crowns, and 3D-printed crowns.
Children between 3 and 7 years of age who need a full-coverage restoration of a primary molar will be invited to participate. Participants will be randomly assigned to receive one of the three crown types. All crowns will be placed by the same dentist using standardized treatment procedures.
After treatment, parents will be asked to complete a questionnaire about their satisfaction with the crown. The questionnaire will evaluate several aspects, including the crown's appearance, size, shape, color, durability, and overall satisfaction. Parent satisfaction will be assessed immediately after crown placement and again one month later.
The purpose of this study is to determine whether there are differences in parent satisfaction among these three crown options. The results may help dentists and families make informed decisions when choosing esthetic full-coverage restorations for primary teeth.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Dental caries remains one of the most common chronic diseases affecting children worldwide. When primary molars are extensively damaged by caries, full-coverage restorations are often indicated to restore function, maintain arch integrity, and preserve the tooth until its natural exfoliation. Traditionally, stainless steel crowns have been widely used for this purpose; however, increasing parental demand for esthetic restorations has led to the development and adoption of alternative crown materials.
Zirconia crowns have gained popularity because of their excellent esthetics, biocompatibility, and durability. Bioflx crowns have emerged as another esthetic option that offers flexibility and ease of placement. More recently, advances in digital dentistry and additive manufacturing have introduced 3D-printed crowns as a potential restorative solution, allowing for customized fabrication and improved esthetic outcomes.
Although these crown systems are increasingly utilized in pediatric dentistry, limited evidence is available regarding parental satisfaction with these treatment options. Parent perception plays an important role in treatment acceptance, adherence to dental recommendations, and overall evaluation of treatment success. Understanding parental preferences and satisfaction may assist clinicians in selecting restorative materials that meet both clinical requirements and family expectations.
This randomized clinical trial is designed to compare parent satisfaction among zirconia crowns, Bioflx crowns, and 3D-printed crowns used for the restoration of primary molars. Eligible children requiring full-coverage restoration of a primary molar will be randomly allocated to one of the three treatment groups. Crown placement procedures will be standardized and performed by the same operator to minimize variability.
Parent satisfaction will be assessed using a structured questionnaire evaluating crown shape, size, color, durability, and overall satisfaction. Assessments will be performed immediately after treatment and at one-month follow-up. The findings of this study may contribute to evidence-based decision making regarding esthetic full-coverage restorations in pediatric dentistry and provide information about factors influencing parental acceptance of different crown types.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Dakahlia Governorate
-
Gamasa, Dakahlia Governorate, Egipto, 11152
- Delta University for Science and Technology
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Indication for full-coverage restoration. Cooperative behavior classified as positive or definitely positive according to the Frankl behavior rating scale.
Parent or legal guardian willing to provide informed consent and agree to random allocation to one of the study groups.
Child medically fit to receive routine dental treatment.
Exclusion Criteria:
- Children requiring advanced behavior management techniques such as sedation or general anesthesia.
Presence of significant systemic medical conditions that may affect oral health or treatment outcomes.
History of failed crown restoration on the same tooth. Teeth with extensive structural destruction that prevents placement of any of the study crown types.
Uncooperative behavior (Frankl negative or definitely negative).
Plan de estudios
¿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 |
|---|---|
|
Experimental: Zirconia Crown Group
Children receiving zirconia full-coverage crowns for primary molars
|
Full-coverage prefabricated zirconia crown used for restoration of primary molars in children.
|
|
Experimental: Bioflx Crown Group
Children receiving Bioflx full-coverage crowns for primary molars
|
Flexible esthetic full-coverage crown used for restoration of primary molars in children.
|
|
Experimental: 3D-Printed Crown Group
Children receiving 3D printed full-coverage crowns for primary molars
|
Custom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parent Satisfaction Score
Periodo de tiempo: Immediately after crown placement and at 1 month follow up
|
Parent satisfaction with the pediatric crown restoration will be assessed using a structured 5-point Likert scale questionnaire. The questionnaire evaluates satisfaction with crown shape, size, color, durability, and overall appearance. Each item is scored as follows:
The primary outcome is the mean parent satisfaction score across the evaluated domains for each crown type (zirconia, Bioflx, and 3D-printed crowns). |
Immediately after crown placement and at 1 month follow up
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Champagne C, Waggoner W, Ditmyer M, Casamassimo PS, MacLean J. Parental satisfaction with preveneered stainless steel crowns for primary anterior teeth. Pediatr Dent. 2007 Nov-Dec;29(6):465-9.
- Alazmah A. Evaluation of Parents and Child Satisfaction Toward Primary Molar Restoration with Preformed Metal Crowns and Its Impact on Child Bullying. Healthcare (Basel). 2025 Dec 26;14(1):62. doi: 10.3390/healthcare14010062.
- Almaghrabi MA, Albadawi EA, Dahlan MA, Aljohani HR, Ahmed NM, Showlag RA. Exploring Parent's Satisfaction and the Effectiveness of Preformed Metal Crowns Fitting by Hall Technique for Carious Primary Molars in Jeddah Region, Saudi Arabia: Findings of a Prospective Cohort Study. Patient Prefer Adherence. 2022 Sep 8;16:2497-2507. doi: 10.2147/PPA.S370159. eCollection 2022.
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
Otros números de identificación del estudio
- 026032213
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .