Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical Trial
Dental anterior open bite is a challenging orthodontic condition with a high risk of relapse in adults. This randomized controlled clinical trial aims to compare the effectiveness and post-treatment stability of in-house clear aligners versus fixed orthodontic appliances in treating adult patients aged 18-30 years with dental anterior open bite (0 to -4 mm).
A total of 46 eligible participants will be randomly allocated into two equal groups (23 treated with clear aligners and 23 with fixed appliances). Treatment outcomes, vertical dentoalveolar changes, and skeletal changes will be evaluated using digital intraoral scans, virtual model superimposition, and lateral cephalometric analysis. Following active treatment, an 8-month retention phase (bonded lingual retainer combined with a vacuum-formed retainer) and an 8-month post-retention follow-up phase will be implemented to comprehensively evaluate treatment stability and relapse tendency over a total observation period of 16 months.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Anterior open bite (AOB) in adults presents significant treatment challenges due to the absence of remaining growth and a high relapse tendency. While fixed orthodontic appliances remain the standard approach for vertical control, clear aligner therapy has gained popularity despite limited randomized controlled evidence regarding its long-term predictability and stability.
This study is designed as a single-center, parallel-group, randomized controlled clinical trial conducted at the Faculty of Dentistry, Sana'a University. Enrolled participants meet strict inclusion criteria: adult age (18-30 years), dental anterior open bite (0 to -4 mm), Class I malocclusion with normal molar relationships, non-extraction treatment requirements (crowding/spacing \le 4\text{ mm}), and good oral hygiene.
Participants in the Clear Aligner group receive fully digital in-house aligners fabricated using Zahndent intraoral scans, 3D Maestro setup software, Elegoo Saturn 4 Ultra 16K printing, and PETG thermoforming sheets (0.75-0.8 mm). Aligner mechanics include optimized attachments and medium power intermaxillary elastics (3-4.5 oz) worn 20-22 hours per day. Participants in the Fixed Appliance group are treated using 0.022-inch MBT prescription brackets with a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and vertical elastics.
Primary and secondary outcomes-including overbite increase, cephalometric vertical changes, treatment efficiency, patient compliance, and satisfaction-will be recorded at baseline, post-treatment, after 8 months of retention, and after 8 months of post-retention follow-up.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Othman Ahmed Othman Ali, BDS, MSc
- Número de telefone: 00967738718234
- E-mail: othman.othman@su.edu.ye
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Adult patients aged 18 to 30 years with fully erupted permanent dentition. Anterior open bite equal to or greater than 2 mm. Angle Class I malocclusion. Good oral hygiene and healthy periodontal status.
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Exclusion Criteria:
- Previous orthodontic treatment. Presence of craniofacial anomalies or cleft lip/palate. Active periodontal disease or severe bone loss. History of temporomandibular joint disorders (TMD). Systemic conditions or medications affecting bone metabolism and tooth movement.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Clear Aligner Group
Participants receive in-house manufactured PETG clear aligners (0.75-0.8 mm) designed with 3D Maestro setup software and printed using Elegoo Saturn 4 Ultra 16K.
Aligners are changed every 10-14 days, combined with optimized composite attachments and medium power intermaxillary vertical elastics (3-4.5 oz) worn 20-22 hours daily.
|
Thermoplastic clear aligners (PETG 0.75-0.8
mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.
Outros nomes:
|
|
Comparador Ativo: Fixed Appliance Group
Participants receive conventional fixed orthodontic appliances with 0.022-inch MBT prescription brackets.
Treatment utilizes a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and intermaxillary vertical elastics.
|
Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overbite Change
Prazo: Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
|
Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.
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Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cephalometric Skeletal Changes
Prazo: Baseline and through study completion, an average of 18 months
|
Changes in vertical and sagittal skeletal relationships (SN-GoGn angle, measured in degrees) evaluated on lateral cephalometric radiographs.
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Baseline and through study completion, an average of 18 months
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Cephalometric Dental Changes
Prazo: Baseline and through study completion, an average of 18 months
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Changes in upper and lower incisor inclinations (U1-SN and L1-MP angles, measured in degrees) evaluated on lateral cephalometric radiographs.
|
Baseline and through study completion, an average of 18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ghamdan Al-Harazi, PhD, Sana'a University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- SU-FD-ORTHO-2026-01
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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