- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07708363
Bracket Positioning Techniques and Quality of Orthodontic Finishing
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
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Cairo Governorate
-
New Cairo, Cairo Governorate, Egito, 11835
- Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group SAP
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
|
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
|
|
Experimental: Group SAMRA
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
|
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
|
|
Comparador Ativo: Group MBT (Control)
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
|
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Prazo: 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.
|
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).
|
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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anterior crown angulation (tip) - CBCT
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Anterior crown inclination (torque) - CBCT
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Maxillary gingival display
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Maxillary incisal display
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Buccal corridor width
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Smile arc category
Prazo: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FUE.REC(42)/10-2024
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .