3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction
5 de agosto de 2026 atualizado por: Lamiaa Farouk, Ain Shams University
Effect of Integrating 3D Facial Scanning in Full-Arch Implant Prosthetics: Time Efficiency and Patient Satisfaction
This study compares two ways of planning the bite (jaw-relation) stage of full-arch, implant-supported dental prosthesis treatment: a standard digital approach, and the same approach with the addition of 3D facial scanning, which lets the dental team plan the new teeth against a scan of the patient's own face.
The study measured how patients felt about their treatment using a validated questionnaire, and also tracked how many clinic visits and adjustments each approach needed.
Twenty-two patients took part, randomly assigned to one of the two approaches.
Visão geral do estudo
Status
Concluído
Descrição detalhada
Full-arch implant-supported prosthetic rehabilitation requires accurate jaw-relation recording, which determines both the functional relationship between the arches and the esthetic integration of the final prosthesis within the patient's face.
Conventional digital workflows rely on intraoral scanning and wax-rim jaw-relation techniques without reference to extraoral facial anatomy.
This prospective, randomized, single-center pilot trial compared a conventional-digital hybrid workflow (Group A) with an enhanced digital workflow incorporating 3D facial scanning (Group B) in patients undergoing full-arch, implant-supported maxillary prosthetic rehabilitation (All-on-6 configuration).
All patients received six implants placed using a fully guided surgical protocol with a stackable surgical guide, followed by an immediately loaded PMMA provisional prosthesis during a three-month osseointegration period.
Following healing, patients were randomly allocated (computer-generated sequence, allocation concealed by an independent third party) to Group A or Group B for the prosthetic (jaw-relation recording) phase.
In Group B, 3D facial scanning was merged with intraoral scans and CBCT data to guide prosthetic design against facial reference planes.
The primary outcome was patient-reported oral health-related quality of life, measured using the validated short-form Oral Health Impact Profile (OHIP-14) questionnaire, administered after four weeks of intraoral trial wear of the try-in prosthesis (T1) and again four weeks after delivery of the definitive prosthesis (T2).
Secondary outcomes included the number of clinical appointments and chairside adjustments required to complete the prosthetic phase, and implant/prosthesis survival at six months.
The definitive prosthesis in both groups consisted of a milled cobalt-chromium framework with layered zirconia, with a mutually protected occlusal scheme.
Outcome assessment (clinical/technical evaluation and statistical analysis) was blinded; blinding of patients and the treating clinician was not feasible given the visibly different nature of the two workflows.
Tipo de estudo
Intervencional
Inscrição (Real)
22
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
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Cairo, Egito
- Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Adults (≥18 years) indicated for full-arch maxillary implant-supported fixed prosthetic rehabilitation
- Completion of the surgical phase with stable implant osseointegration
- Presence of healthy peri-implant soft tissues
- Adequate oral hygiene status
- Sufficient bone and soft-tissue conditions compatible with full-arch prosthetic rehabilitation
- Ability to comply with all scheduled follow-up visits
- Capacity to maintain natural head position during facial scanning procedures
- Absence of significant gag reflex interfering with scanning/impression procedures
- Ability to communicate effectively and complete questionnaires
- Provision of written informed consent
- Physically and psychologically fit for the planned treatment
Exclusion Criteria:
- Severe skeletal or orthognathic discrepancies
- History of significant facial trauma or surgery affecting facial symmetry
- Prior maxillofacial pathology affecting the surgical/prosthetic site
- Uncontrolled systemic diseases affecting healing or treatment tolerance
- Use of medications that alter osseointegration or facial soft tissues
- Active oral or peri-implant infection
- Neuromuscular disorders or temporomandibular joint dysfunction affecting jaw positioning
- Conditions affecting the ability to maintain stable head position for scanning
- Severe psychomotor limitations
- Known hypersensitivity to materials used in bite registration or prosthesis fabrication
- Inability or unwillingness to provide informed consent
- Pregnancy or lactation, if deemed a contraindication by the supervising clinician
- Poor compliance or demonstrated unreliability in past dental or medical care
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 |
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Comparador Ativo: Conventional-Digital Hybrid Workflow
aw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, without facial scanning.
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Jaw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, w
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Experimental: Enhanced Digital Workflow with 3D Facial Scanning
Same base digital workflow as Group A, with the addition of high-resolution 3D facial scanning (Shining 3D structured-light scanner), merged with intraoral scans and CBCT data via Exocad software to guide prosthetic alignment against extraoral facial landmarks.
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Integration of 3D facial scanning into the jaw-relation recording stage of full-arch implant prosthetic rehabilitation, merging facial, intraoral, and CBCT datasets to guide prosthetic design against facial reference planes.
Performed in addition to the same base digital workflow described in Intervention 1.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
Prazo: 4 weeks
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Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse).
Assessed after the patient had worn the try-in (trial) prosthesis intraorally for four weeks (T1).
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4 weeks
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint
Prazo: 4 weeks
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Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse).
Assessed four weeks after delivery of the definitive prosthesis (T2).
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4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Clinical Appointments to Complete the Prosthetic Phase
Prazo: up to 12 weeks
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Total number of clinic visits from jaw-relation registration through prosthesis delivery.
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up to 12 weeks
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Number of Try-In Adjustments
Prazo: up to 8 weeks
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Number of chairside occlusal corrections (selective grinding, material addition, or jaw-relation re-verification) required at try-in before definitive fabrication.
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up to 8 weeks
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Implant and Prosthesis Survival / Complications at 6 Months
Prazo: 6 months post-delivery
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Clinical review for implant failure, prosthesis fracture, or other mechanical/biological complications.
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6 months post-delivery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
31 de outubro de 2024
Conclusão Primária (Real)
1 de setembro de 2025
Conclusão do estudo (Real)
25 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
1 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2026
Primeira postagem (Real)
7 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- FDASU-Rec IR/M102515
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared.
The original informed consent obtained from participants covered their participation in this study but did not include provisions for the public sharing of individual-level, de-identified data with third parties or external researchers.
In addition, given the small sample size (n = 11 per group) within a single department, there is a meaningful risk that even de-identified individual-level data could be re-identified.
No data-sharing repository or access infrastructure has been established for this dataset.
Aggregate, de-identified results are reported in the published thesis and any resulting publications.
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 .