- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07655193
Improving Decision-Making for Missing Upper Front Teeth
Development of a Patient Decision Aid for the Treatment of Maxillary Lateral Incisor Agenesis
Background: The developmental absence of 1-2 upper front teeth is a common condition, affecting 1 in 50 people worldwide, and affects smile aesthetics and quality-of-life. Treatment is often undertaken in teenagers, but the outcomes have lifelong consequences. Treatment options involve either creating space for a false tooth, or closing space and disguising the adjacent tooth as the missing tooth; both options have their own advantages, disadvantages and long-term considerations, and treatment often requires input from multiple dental specialties. Advances in orthodontic techniques mean more patients can be treated with either approach, therefore, the ideal treatment plan becomes more subjective and based upon the patient's preferences.
Aim: To develop a Patient Decision Aid (PDA), a decision-making support tool to help young people (and parents/guardians) with developmentally missing upper front teeth choose the best treatment option for them.
Approach: First, the investigators will gather information from stakeholders involved in the decision-making process to understand their needs. Interviews will be conducted with young people with developmentally missing upper front teeth and their parents/guardians about their experiences, expectations, and preferences regarding treatment decision-making. Information will also be sought from clinicians involved in this process about their experiences of the decision-making process, via focus groups. These will be carried out across two NHS hospitals with special clinics for missing teeth. Then, the information obtained from both patient and clinician stakeholder groups will help the investigators to develop a PDA, following international guidelines. PDA development will occur alongside ongoing input and feedback from a Development Panel (which will include patients and clinician representatives) to optimise content, acceptability, and accessibility. The final approved PDA will then be trialled in a later pilot study.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Patient Participant Inclusion Criteria:
- Young people with Maxillary Lateral Incisor Agenesis (MLIA) affecting one or both maxillary lateral incisors
- Young people aged 11-18 years old (attending with an adult with parental responsibility if <16 years old)
- In active orthodontic (space-closure or space-opening) or restorative treatment for MLIA, or completed active dental treatment less than one year ago
- Attended a multidisciplinary Hypodontia Clinic for treatment planning where both space-closure and space-opening options were offered
Patient Participant Exclusion Criteria:
- Craniofacial anomalies including cleft lip and/or palate
- Unable to communicate in English where no professional translation service is available
Clinician Participant Inclusion Criteria:
- Specialists or consultants in orthodontics, restorative dentistry, paediatric dentistry, and oral surgery who provide care as part of the Hypodontia pathway and work within the multidisciplinary hypodontia clinics
Clinician Participant Exclusion Criteria:
- Any clinician not providing care as part of the Hypodontia pathway and working within the multidisciplinary hypodontia clinics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients
Young people with Maxillary Lateral Incisor Agenesis (+/- parent or guardian)
|
Interviews with patient participants and focus groups with clinician participants will be used to elicit information about experiences with decision-making with regards to treatment options for Maxillary Lateral Incisor Agenesis.
|
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Clinicians
Any clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs.
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Interviews with patient participants and focus groups with clinician participants will be used to elicit information about experiences with decision-making with regards to treatment options for Maxillary Lateral Incisor Agenesis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Qualitative experience
Periodo de tiempo: Day 1
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Qualitative data from interviews / focus groups on experiences of treatment decision-making for MLIA, which will be thematically analysed using the Framework method.
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Day 1
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Enfermedades Estomatognáticas
- Enfermedades de los dientes
- Anomalías del sistema estomatognático
- Anomalías congénitas
- Anomalías dentales
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Anodoncia
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Entrevistas como tema
- Grupos focales
Otros números de identificación del estudio
- 359545
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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. .