- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04975321
Clinical Trial NuSmile Crowns
A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98115
- University of Washington-The Center for Pediatric Dentistry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients of record at the University of Washington's Center for Pediatric Dentistry
- Patients in general good health (ASA I)
- Patients aged 5 years old or younger
- Patients in need of at least one preformed crowns, on anterior primary teeth
- Patients undergoing general anesthesia for dental treatment
- Parent or guardian of patient able and willing to provide informed consent
Exclusion Criteria:
- Medically compromising condition
- Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
- Teeth with complete absence of facial or lingual walls following tooth preparation
- Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
- Anterior crowding
- Occlusion class III
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Nu Smile Zirconia crown
Anterior primary teeth which received a NuSmile zirconia crown as a final restoration
|
Placement of an anterior primary crown restoration
|
Comparateur actif: Nu Smile pre veneered crown
Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration
|
Placement of an anterior primary crown restoration
|
Comparateur actif: Composite strip crown
Anterior primary teeth which received a composite strip crown as a final restoration
|
Placement of an anterior primary crown restoration
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Fitting
Délai: 12 months
|
The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention
A higher score means a worse outcome |
12 months
|
Positioning
Délai: 12 months
|
Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position
A higher score means a worse outcome |
12 months
|
Proximal Contact
Délai: 12 months
|
The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces
A higher score means a worse outcome |
12 months
|
Marginal Adaptation
Délai: 12 months
|
The number of teeth scored in the marginal adaptation categories as described below Marginal adaptation 0= No discrepancies detected with explorer
A higher score means a worse outcome |
12 months
|
Color
Délai: 12 months
|
The number of teeth scored in the color categories described below Color matching 0= Matches completely or within range of shade and translucency
A higher score means a worse outcome |
12 months
|
Gingival Status
Délai: 12 months
|
The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation
A higher score means a worse outcome |
12 months
|
Retention of the Crown
Délai: 12 months
|
The number of teeth scored in the retention of the crown categories described below Retention of the crown 0= Intact 1= Partially missing 2 = Missing - some cement remaining on both tooth and crown interior A higher score means a worse outcome |
12 months
|
Integrity of the Veneer/Composite
Délai: 12 months
|
The number of teeth scored in the integrity of the veneer/composite categories described below Integrity of veneer/ composite 0= Intact
A higher score means a worse outcome |
12 months
|
Secondary Caries
Délai: 12 months
|
The number of teeth scored in the secondary caries categories described below Secondary caries 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
History of Trauma
Délai: 12 months
|
The number of teeth scored in the history of trauma categories described below History of trauma 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
Clinical Pulp Pathology
Délai: 12 months
|
The number of teeth scored in the clinical pulp pathology categories described below Clinical pulp pathology 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
Radiographical Pulp Pathology
Délai: 12 months
|
The number of teeth scored in the radiographical pulp pathology categories described below Radiographical pulp pathology 0= Absent 1= Present A higher score means a worse outcome A higher score means a worse outcome |
12 months
|
Parent's Esthetic Satisfaction
Délai: 12 months
|
The number of teeth scored in the parent's esthetic satisfaction categories described below Parents esthetic satisfaction via a survey 0=Satisfied 1= Dissatisfied A higher score means a worse outcome |
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mariella Garcia, DDS, University of Washington
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00003980
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
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Nu Smile Zirconia crown
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