- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07705009
Intraoral Scanning Versus Alginate Impressions in Dental Students
Procedure Time and Patient Comfort of Intraoral Scanning Versus Alginate Impressions Among Dental Students: A Randomized Clinical Trial
Dental impressions are used to create a record of a person's teeth and oral structures. Conventional impressions are made using impression material placed in a tray, whereas digital impressions are obtained using an intraoral scanner.
This randomized clinical trial compared conventional alginate impressions with digital intraoral scanning using the TRIOS 3 and Medit i700 scanners among dental students aged 18 to 24 years. Participants were randomly assigned to one of the three impression techniques. Each participant underwent recording of both the upper and lower dental arches using the assigned technique.
The study primarily compared the chairside time required for each technique and the participants' experience immediately after the procedure. Comfort, nausea, breathing, pain, dry-mouth sensation, perceived procedure speed, overall satisfaction, and preference for conventional or digital impressions were also evaluated.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Huế, Viêt Nam, 530000
- Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Undergraduate dental students at the University of Medicine and Pharmacy, Hue University.
- Aged 18 to 24 years.
- Willing to undergo one maxillary and one mandibular dental impression using the assigned technique.
- Willing and able to complete the study questionnaire.
- Provided written informed consent.
Exclusion Criteria:
- Currently undergoing orthodontic treatment.
- Presence of a systemic disease or acute condition that limited the ability to cooperate or increased the risk of discomfort during impression taking or intraoral scanning, including an acute respiratory disorder or frequent vomiting.
- Limited mouth opening or an oral and maxillofacial condition that prevented correct impression-tray seating or scanner-tip placement according to the study protocol.
- A maxillofacial abnormality that markedly affected the procedure or caused significant recording distortion.
- An excessive gag reflex that prevented completion of the assigned procedure.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Conventional Alginate Impression
Participants underwent maxillary and mandibular conventional impressions using alginate impression material and stock trays according to the manufacturer's instructions.
|
Maxillary and mandibular conventional impressions were obtained using Tropical alginate impression material and stock trays.
The alginate was mixed, placed in the impression tray, and used according to the manufacturer's instructions.
|
|
Expérimental: TRIOS 3 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
|
Maxillary and mandibular full-arch digital impressions were obtained using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
|
|
Expérimental: Medit i700 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
|
Maxillary and mandibular full-arch digital impressions were obtained using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Chairside Procedure Time
Délai: During the assigned impression procedure at the single study visit
|
Total chairside procedure time was measured in seconds using a digital stopwatch and calculated as the sum of the recorded procedural stages.
For the conventional alginate group, the stages included maxillary mixing, maxillary impression taking, mandibular mixing, and mandibular impression taking.
For the digital groups, the stages included patient and case information entry, maxillary scanning, and mandibular scanning.
Bite-registration time was excluded from the total procedure time because there was no equivalent stage in the conventional alginate workflow.
|
During the assigned impression procedure at the single study visit
|
|
Patient-Reported Overall Comfort During the Impression Procedure
Délai: Immediately after completion of the assigned impression procedure
|
Overall comfort during the assigned impression procedure was assessed immediately after the procedure using a 0-to-100 visual analogue scale.
Higher scores indicated greater comfort.
|
Immediately after completion of the assigned impression procedure
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Van Nhat Thang Le, DDS PhD, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
Publications et liens utiles
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
Autres numéros d'identification d'étude
- H2025/074
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 .