Bracket Positioning Techniques and Quality of Orthodontic Finishing
10 de julio de 2026 actualizado por: Hager Mansour Abdelbaseer Zoghby, Future University in Egypt
Comparison of Three Bracket Positioning Techniques (Smile Arc Protection, Smile Arc and Marginal Ridge Approach, and McLaughlin-Bennett-Trevisi) on the Quality of Orthodontic Finishing, Mini-Esthetics, and Anterior Tooth Tip and Torque: A Three-Arm Randomized Clinical Trial
This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and mild-to-moderate crowding treated non-extraction.
The primary aim is to determine which technique yields the highest quality of orthodontic finishing, measured with the American Board of Orthodontics Objective Grading System (ABO-OGS).
Secondary aims compare anterior tooth tip and torque (assessed by CBCT) and mini-esthetic smile parameters (gingival display, incisal display, buccal corridor, and smile arc, assessed on standardized posed-smile photographs) among the three techniques.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Bracket positioning is one of the most influential operator-dependent factors affecting the quality of orthodontic finishing and the resulting smile esthetics. Three contemporary positioning philosophies are compared in this trial.
Design. Eligible participants are randomly allocated 1:1:1 to one of three parallel arms. Allocation is generated with an online randomizer, concealed in sequentially opaque sealed envelopes held by a co-supervisor, and revealed only on the day of intervention. Outcome assessors are blinded; operator blinding is not feasible.
Intervention. All arms receive a fully digital indirect-bonding workflow (intraoral scanning, virtual bracket placement in 3Shape Ortho-Analyzer, 3D-printed casts, vacuum-formed transfer trays) using a 0.018-inch MBT prescription, and an identical arch wire sequence ending in a 0.017 in × 0.025 in stainless steel wire maintained for three months. The arms differ only in the vertical/angular bracket-positioning rule applied (SAP, SAMRA, or MBT chart).
Assessment. Records are captured before bonding (T₀) and at the end of levelling and alignment (T₁). The ABO-OGS is scored on 3D-printed casts and the panoramic radiograph; tip and torque are measured on dentoalveolar CBCT; mini-esthetic parameters are measured on standardized frontal posed-smile photographs calibrated in Adobe Photoshop.
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Cairo Governorate
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New Cairo, Cairo Governorate, Egipto, 11835
- Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Males and females aged 14-25 years with a full permanent dentition.
- Mild to moderate crowding requiring non-extraction orthodontic treatment (2-6 mm per Graber's classification).
- Angle Class I malocclusion.
- Normal skeletal vertical dimension (SN-MP angle 32° ± 5°).
Exclusion Criteria:
1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
2. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
4. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group SAP
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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Experimental: Group SAMRA
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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Comparador activo: Group MBT (Control)
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Periodo de tiempo: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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Total ABO-OGS score obtained on the Cast-Radiographic Evaluation (CRE) form.
Seven parameters - alignment/rotations, marginal ridges, buccolingual inclination, occlusal contacts, occlusal relationships, overjet, and interproximal contacts - are scored on 3D-printed casts with the ABO measuring gauge; root angulation is scored on the panoramic radiograph.
Point deductions are summed to give the total score (a lower total indicates better finishing).
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At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anterior crown angulation (tip) - CBCT
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Anterior crown inclination (torque) - CBCT
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary gingival display
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary gingival display - the vertical distance (mm) between the inferior border of the upper lip and the gingival zenith of each maxillary anterior tooth (central incisor, lateral incisor, canine, both sides) on standardized posed-smile frontal photographs, measured in Adobe Photoshop after calibration against a metric ruler.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary incisal display
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary incisal display - the vertical amount (mm) of maxillary incisor crown visible relative to the upper lip during a posed smile, on standardized photographs.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Buccal corridor width
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in buccal corridor (lateral negative space) - the linear distance (mm) between the most posterior visible maxillary tooth and the corner of the mouth during posed smile, measured on each side and averaged.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc category
Periodo de tiempo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc classified as consonant, flat, or reversed based on the relationship between the curvature of the maxillary incisal/canine/premolar edges and the curvature of the lower lip during posed smile.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2024
Finalización primaria (Actual)
1 de julio de 2026
Finalización del estudio (Actual)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FUE.REC(42)/10-2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Study data are stored confidentially within the Department of Orthodontics with access restricted to the investigator and supervisors; results will be disseminated through the institutional thesis repository and peer-reviewed publication.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .