- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fayrouz Fayrouz Esam Ahmed Taher Mahmoud
- Número de teléfono: 0201016926903
- Correo electrónico: fayrouzesam17@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: Modified Marcotte Loop
orthodontic patient treated by modified Marcotte spring for canine retraction.
|
orthodontic patient treated by Modified Marcotte spring for canine retraction.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Maxillary Canine Retraction
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Canine Retraction with Loops
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .