Digital vs. Conventional Indirect Bonding.
Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches.
Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.
In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.
The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lorenzo Franchi
- Numéro de téléphone: +390557945602
- E-mail: lorenzo.franchi@unifi.it
Lieux d'étude
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-
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Florence, Italie
- Recrutement
- Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
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Contact:
- Lorenzo Franchi
- Numéro de téléphone: +390557945602
- E-mail: lorenzo.franchi@unifi.it
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches
- Presence of full permanent dentition, including erupted second molars
Exclusion Criteria:
- Presence of dental anomalies in number (supernumerary or missing teeth) in either arch
- Orthodontic treatment plans involving tooth extractions in either arch
- Nickel allergy
- History of cleft lip and/or palate
- Craniofacial syndromes
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 |
|---|---|
|
Expérimental: Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch
Participants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch.
|
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
|
|
Comparateur actif: Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch
Participants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.
|
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time required to complete bracket bonding procedures, measured in minutes
Délai: During procedure (from the beginning of bracket bonding to completion of bracket placement)
|
The time required to complete the bracket bonding procedure will be measured in minutes for each participant, from the beginning of the bonding procedure to completion of bracket placement, using the assigned adhesive system.
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During procedure (from the beginning of bracket bonding to completion of bracket placement)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination
Délai: 1 month after placement of the fixed orthodontic appliance
|
Bracket failure will be assessed by clinical examination and recorded as the number of brackets detached from the tooth surface within the first month after placement of the fixed orthodontic appliance.
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1 month after placement of the fixed orthodontic appliance
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Autres numéros d'identification d'étude
- LF17
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.
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