Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
3 de setembro de 2026 atualizado por: Baskent University
Comparison of the Skeletal and Dentoalveolar Effects and Patient Comfort of Conventional and 3D-Printed Maxillary Expansion Appliances in Mixed Dentition Patients
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth).
The main questions this study aims to answer are:
- Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances?
- Do children feel more comfortable with one type of appliance?
- Is there a difference in pain levels or oral hygiene between the two groups?
Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort.
Participants:
- Being treated with one of the two expansion appliances (assigned randomly)
- Follow a standard activation protocol at home with parental guidance
- Attend regular clinic visits during expansion and retention phases
- Have dental photographs, X-rays, and digital scans taken before and after treatment
- Complete an oral health-related quality of life questionnaire
- Rate their pain using a pain scale
- Have their oral hygiene measured
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
Treatment effectiveness, amount of expansion, and patient comfort will be evaluated between the two groups. Additionally, the impact of digital appliance production on treatment outcomes and patient satisfaction will be investigated.
This prospective, parallel-group, randomized clinical trial aims to compare the skeletal, dentoalveolar, and patient-reported effects of conventionally fabricated and three-dimensional (3D) printed rapid maxillary expansion (RME) appliances in children with transverse maxillary deficiency during the mixed dentition period.
Participants aged 8-10 years who meet the predefined inclusion criteria and require rapid maxillary expansion as part of their orthodontic treatment will be enrolled.
The results are expected to contribute evidence-based guidance for orthodontists when selecting appliance fabrication methods, balancing biological effectiveness with patient comfort and quality-of-life considerations.
Findings from this study may also support future digital workflow integration strategies in pediatric orthodontic treatment planning.
Tipo de estudo
Intervencional
Inscrição (Real)
48
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Ankara, Turquia (Türkiye), 06490
- Baskent University Faculty of Dentistry, Department of Orthodontics
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Children aged between 7 and 11 years
- In the mixed dentition period
- Fully erupted permanent first molars
- Presence of primary canines and primary second molars suitable for use as anchorage units for at least 6 months
- Angle Class I or Class II molar relationship
- Presence of posterior crossbite and/or moderate maxillary transverse deficiency or moderate crowding
- Prepubertal growth stage corresponding to Cervical Vertebral Maturation Stage 1 (CVM1) or Stage 2 (CVM2)
- Receiving orthodontic treatment at the Başkent University Department of Orthodontics
- Parents or legal guardians willing to provide written informed consent
Exclusion Criteria:
- Previous orthodontic treatment
- Periodontal disease
- Enamel hypocalcification or significant calcium deficiency
- Root resorption
- Signs or symptoms of temporomandibular joint dysfunction
- Angle Class III molar relationship
- Craniofacial syndromes
- Cleft lip and/or palate
- Known allergy to acrylic materials or metal alloys
- Inability to maintain adequate oral hygiene during treatment
- Lack of cooperation during treatment
- Repeated appliance breakage or dislodgement (three or more times)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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: Laboratory-fabricated rapid maxillary expansion appliance
Participants are treated with a laboratory-fabricated rapid maxillary expansion (RME) appliance produced on a dental cast obtained from conventional impressions.
The arms of the palatal expansion screw are adapted and soldered to orthodontic molar bands on the cast model.
Following adaptation, acrylic resin is added in the palatal region to increase the force distribution area.
The appliance is cemented to the teeth using glass ionomer cement.
Activation and retention protocols are standardized across both groups.
|
A rapid maxillary expansion (RME) appliance fabricated on a dental cast obtained from conventional impressions.
The expansion screw arms are adapted and soldered to orthodontic molar bands on the cast.
Outros nomes:
|
|
Experimental: 3D-printed rapid maxillary expansion appliance
Participants are treated with a rapid maxillary expansion (RME) appliance fabricated using digital intraoral scans.
Dental models are generated from intraoral scan data, and the appliance framework, including the arms and tooth-supporting components, is manufactured as a single-piece structure using three-dimensional (3D) metal printing technology with sintered cobalt-chromium alloy.
After fabrication, acrylic resin is added to the palatal region to increase the force distribution area.
The appliance is cemented to the teeth using glass ionomer cement.
Activation and retention protocols are standardized across both groups.
|
A rapid maxillary expansion (RME) appliance fabricated using digital intraoral scan data.
Dental models are generated from intraoral scans, and the appliance framework is manufactured as a single-piece structure using three-dimensional (3D) metal printing with sintered cobalt-chromium alloy.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Prazo: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
The primary outcome is the difference in transverse skeletal maxillary width and maxillary intermolar width between baseline (T0) and the end of the 3-month retention period (T2).
Skeletal measurements will be obtained from standardized posteroanterior cephalometric radiographs, and dental measurements will be obtained from digital model analysis.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale score
Prazo: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at predefined time points during treatment.
Scores will be recorded and compared between groups.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
|
Child Perceptions Questionnaire (CPQ 8-10)
Prazo: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Oral health-related quality of life will be assessed using the validated Child Perceptions Questionnaire (CPQ 8-10).
Total and domain scores (oral symptoms, functional limitations, emotional well-being, social well-being) will be recorded and compared between groups.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
|
Modified Silness-Löe Plaque Index score
Prazo: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Oral hygiene status will be evaluated using the Modified Silness-Löe Plaque Index at predefined time points during treatment to monitor plaque accumulation and compare oral hygiene changes between groups.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
3D digital model superimposition-based surface deviation
Prazo: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Digital models obtained at T0 and T2 will be superimposed using the medial two-thirds of the third palatal rugae and the posterior palatal vault as stable reference areas.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Habibe Sinem Ince Bingol, DDS, Orthodontist, Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
- Investigador principal: Sinem Tekdemir, DDS, Baskent University, Faculty of Dentistry, Department of Orthodontics
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de agosto de 2025
Conclusão Primária (Real)
31 de julho de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
23 de fevereiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D-KA24/41
- 2025-066 (Outro identificador: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)
- 25/31 (Outro identificador: Baskent University Institutional Ethics Committee Approval Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .