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- Essai clinique NCT07826182
Comparison Between Two Different Loops for Maxillary Canine Retraction
Comparison Between Two Different Loops for Maxillary Canine Retraction (Split Mouth Technique)(Randomized Clinical Study)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Orthodontic management of severe dental crowding and dentoalveolar protrusion frequently necessitates the extraction of maxillary first premolars. Following extraction, space closure is typically executed in a two-step procedure, initiated by isolated canine retraction to provide adequate space for subsequent incisor alignment and retraction.
Because canine retraction spans the longest duration of the space-closure phase, optimizing this stage is critical to achieving rapid, controlled tooth movement while minimizing adverse clinical effects like anchorage loss, root resorption, and unwanted tooth tipping or rotation.
In clinical orthodontics, canine retraction can be achieved through two primary biomechanical modalities: friction (sliding) mechanics and frictionless (loop/sectional) mechanics. While sliding mechanics are highly valued for their clinical simplicity, they generate significant frictional forces and binding at the bracket-arch wire interface. This friction can dissipate a substantial portion of the applied orthodontic force, cause unpredictable tooth movement and increase the risk of posterior anchorage strain. Conversely, frictionless mechanics eliminate these interface variables by utilizing specialized sectional wire loops to generate the required forces.
The success of frictionless canine retraction relies heavily on the structural design and configuration of the loop used.
Different loop designs such as the classic Burstone T-loop, the Opus loop, and the modified Marcotte spring exhibit distinct biomechanical properties:
- Load-Deflection Rate (LDR): Determines how rapidly the force decays as the tooth moves. A lower LDR provides a safer, more constant force over time.
- Moment-to-Force (M: F) Ratio: Governs the type of tooth movement achieved. Achieving a precise M:F ratio is mandatory to prevent uncontrolled distal tipping and promote controlled tipping or bodily movement (translation).
Despite extensive laboratory and limited element analyses detailing the theoretical behavior of various loop designs, translating these findings into real-world performance remains challenging. Individual biological variations such as; bone remodeling rates, alveolar bone density, and patient compliance introduce confounding variables that can twist clinical outcomes in traditional parallel-group clinical trials. To overcome these biological limitations, a split-mouth study design serves as an ideal methodology.
By randomly assigning different loop mechanics to opposing quadrants within the same maxillary arch of a single patient, each subject acts as their own perfectly matched control, effectively eliminating systemic biological bias. Recent clinical trials utilizing this design have started to clarify differences in loop efficiency.
For instance, comparisons between the Opus loop and the T-loop have demonstrated subtle variations in retraction rates, though both maintain comparable overall clinical performance.
Similarly, investigations contrasting the T-loop against alternative segmental systems, such as dual-force retractors or modified Marcotte springs, emphasize that loop configuration directly influences the duration of retraction, three-dimensional torque control, and the preservation of posterior anchorage.
While several clinical trials have compared sliding versus loop mechanics, head-to-head clinical comparisons evaluating efficiency, anchorage control, rotational tendencies, and patient comfort levels between different modern loop designs remain scarce. Consequently, there is an ongoing clinical debate regarding which loop configuration yields the most favorable balance between rapid canine retraction and optimal three-dimensional position control.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fayrouz Fayrouz Esam Ahmed Taher Mahmoud
- Numéro de téléphone: 0201016926903
- E-mail: fayrouzesam17@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 16-25 years.
- Class I or II div 1 malocclusion with moderate to severe crowding who are indicated for maxillary premolar extraction.
- Good oral hygiene and general health.
- Full eruption of maxillary permanent canines and second molars.
Exclusion Criteria:
- Systemic disease affecting bone remodeling eg.DM
- Previous extraction of permanent teeth.
- Periodontal disease or radiographic evidence of bone loss.
- Previous orthodontic treatment.
- Craniofacial anomalies or cleft lip and palate.
- Skeletal asymmetry.
- Orthodontic cases that could be treated with no indication for extraction
- Orthodontic cases that are indicated for extraction of any tooth other than maxillary first premolars.
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: Poul Gjessing (PG) Loop
orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
|
orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
|
|
Expérimental: Modified Marcotte Loop
orthodontic patient treated by modified Marcotte spring for canine retraction.
|
orthodontic patient treated by Modified Marcotte spring for canine retraction.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Maxillary Canine Retraction
Délai: At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
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
Autres numéros d'identification d'étude
- Canine Retraction with Loops
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
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 .