- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
|
Clinicians
Any clinicians involved in multidisciplinary hypodontia clinics where treatment decision-making occurs.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Qualitative experience
Délai: Day 1
|
Qualitative data from interviews / focus groups on experiences of treatment decision-making for MLIA, which will be thematically analysed using the Framework method.
|
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies stomatognathiques
- Maladies dentaires
- Anomalies du système stomatognathique
- Anomalies congénitales
- Anomalies dentaires
- Maladies et anomalies congénitales, héréditaires et néonatales
- Anodontie
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Entretiens comme sujet
- Groupes de discussion
Autres numéros d'identification d'étude
- 359545
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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