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Digital VS Conventional Altered Cast Technique for Mandibular Bilateral Distal Extension RPDs

7 de maio de 2026 atualizado por: Kareem Mohammed Reda, Tanta University

Digital VS Conventional Altered Cast Technique for Mandibular Bilateral Distal Extension Removable Partial Denture

This study aims to compare outcomes of digitally created altered casts with conventional altered casts in mandibular bilateral distal-extension cases.

Visão geral do estudo

Descrição detalhada

Partially dentate adults represent an increasing proportion of the population, driven by increased life expectancy and a demographic shift from total edentulism toward partial edentulism. Fabrication of removable partial dentures for distal extension edentulous ridges presents significant clinical complexity because the teeth and residual ridge possess fundamentally different degrees of displaceability. Optimum denture support re-quires recording teeth in anatomical form and the mucosa in functional form .

The altered cast impression technique , introduced by Applegate, remains one of the most widely accepted methods for achieving optimal tissue support and accurate denture base positioning relative to tooth abutments . removable partial dentures fabricated using altered cast impression technique demonstrate improved patient comfort and preservation of oral health . However, despite these advantages, debate persists regarding the clinical significance of altered cast impression technique over single-impression techniques .

Recent advances in computer-aided design and computer-aided manufacturing have transformed the removable partial dentures framework, opening new pathways in the fabrication of RPD through additive and subtractive manufacturing . Digital intraoral scanning offers advantages, including reduced dimensional error, improved efficiency, and real-time feedback on impression accuracy and extension [13-16]. However, intraoral scanning techniques are inherently mucostatic and image-based, rendering the recording of functional impression impossible, a limitation acknowledged as necessary for optimal support in distal extension removable partial dentures . Lab scanning of conventionally prepared altered casts pre-pared by traditional methods fails to eliminate inherited errors from cast separation and reassembly.

Recent studies have introduced hybrid digital workflows that combine functional registration of the edentulous ridge with mucostatic scanning of the remaining oral structures in an effort to reproduce conventional clinical procedures while improving efficiency and precision . Most investigations on digital technology in RPD have concentrated on methods for fabricating metal frameworks and evaluating their performance.

This study aims to compare outcomes of digitally created altered casts with conventional altered casts in mandibular bilateral distal-extension cases.

Tipo de estudo

Intervencional

Inscrição (Real)

7

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

      • Tanta, Egito
        • Tanta University

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

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Patients presented with bilateral, well-formed mandibular distal extension residual ridges covered by keratinized mucosa, with a minimum thickness of 1.5-3 mm .
  • Each participant had a sound first or second premolar serving as the terminal abutment, with a crown-to-root ratio of ≥ 1:2.
  • Comprised fully or partially dentate maxillary arches, an Angle Class I molar relationship, and adequate interarch space (7-8 mm) to accommodate the prosthesis .

Exclusion Criteria:

  • The presence of systemic conditions affecting bone metabolism or healing
  • pathological conditions in the edentulous area (e.g., residual cysts, retained roots, or severe ridge re-sorption);
  • parafunctional habits such as bruxism, clenching, or tongue thrusting
  • pro-nounced anatomical undercuts in the lingual mandible or adjacent to abutment teeth that could impede denture fabrication or insertion.

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Digital workflow and Digital altered cast group
Digital selective tissue placement was performed within the same Exocad design project using the free-form scan-data tool, paint and pull feature to apply the principles of selective tissue pressure technique . Using free form mesh editing tools, the buccal shelf area opposing teeth 37 and 47 was identified, and controlled tissue ward displacement of the mucosal surface was simulated while monitoring the magnitude of displacement on sectional views and with digital measurement tools. Figure 2B, F The modified mandibular dataset was saved as the digitally altered cast STL (DA), which served as the basis for the digital RPD design and subsequent denture base fabrication.
The RPD design features of fully digitally fabricated RPD illustrated in Figure 2A. Digital selective tissue placement was performed within the same Exocad design project using the free-form scan-data tool, paint and pull feature to apply the principles of selective tissue pressure technique . Using free form mesh editing tools, the buccal shelf area opposing teeth 37 and 47 was identified, and controlled tissue ward displacement of the mucosal surface was simulated while monitoring the magnitude of displacement on sectional views and with digital measurement tools.
Experimental: Conventional workflow and conventional altered cast group
For the CA cast technique, one of the SLM frameworks (MF2) was adapted on the stone master cast and used as a functional impression tray (Acrostone Dental Manufacturing, Cairo, Egypt) over the distal extension areas. A selec-tive pressure impression was made according to the traditional altered cast protocol, with the distal saddle areas repoured in dental stone to obtain the CA cast. This CA was then digitized using a desktop scanner (Dove Technologies, Suzhou, China) to produce the CA cast STL. Wax rims were used to verify the jaw relationship, and the maxillary cast was mounted using a facebow transfer on a semi adjustable articulator (A7 Plus, Bio-Art Equi-pamentos Odontológicos Ltda., São Carlos, SP, Brazil), while the mandibular cast was mounted in maximum intercuspation.
For the CA cast technique, one of the SLM frameworks (MF2) was adapted on the stone master cast and used as a functional impression tray (Acrostone Dental Manufacturing, Cairo, Egypt) over the distal extension areas. A selec-tive pressure impression was made according to the traditional altered cast protocol, with the distal saddle areas repoured in dental stone to obtain the CA cast. This CA was then digitized using a desktop scanner (Dove Technologies, Suzhou, China) to produce the CA cast STL. Wax rims were used to verify the jaw relationship, and the maxillary cast was mounted using a facebow transfer on a semi adjustable articulator (A7 Plus, Bio-Art Equi-pamentos Odontológicos Ltda., São Carlos, SP, Brazil), while the mandibular cast was mounted in maximum intercuspation. Semi anatomic acrylic teeth (Acrostone Dental Manufacturing, Cairo, Egypt.) were arranged, and wax try ins were evaluated intraorally in a conventional manner prior to processing.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Assessment of the condition of ridge mucosal covering of the Removable Partial Denture constructed out of digitally altered model.
Prazo: at 15 days, 3 months and 6 months .
at 15 days, 3 months and 6 months .

Medidas de resultados secundários

Medida de resultado
Prazo
Denture base fit by Pressure Indicating Paste
Prazo: one month
one month

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)

30 de maio de 2021

Conclusão Primária (Real)

30 de novembro de 2024

Conclusão do estudo (Real)

30 de novembro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

1 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2026

Última verificação

1 de maio de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • R-RP-5-21-10

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 .

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