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- Ensaio Clínico NCT07827755
Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Endodontically treated maxillary anterior teeth frequently present with significant loss of coronal tooth structure, compromising their resistance to fracture and complicating restoration. prefabricated fiber posts are widely used to retain a composite core prior to crown placement, but the degree to which a post adapts to the internal canal wall - leaving minimal or no gap between the post and the remaining gutta-percha - may influence long-term clinical performance and resistance to microleakage.
This study is a randomized controlled trial comparing a custom-adapted ultra-high-molecular-weight polyethylene (UHMWPE) fibers post (Ribbond-type), individually formed to the canal anatomy, against a prefabricated fiber post. Eligible teeth are endodontically treated maxillary anterior teeth with 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction, where any remaining sound walls meet a minimum height of 1.5-2 mm and a circumferential thickness of approximately 1 mm, in line with established ferrule criteria.
Participants will be randomly allocated to receive either the Ribbond post or the prefabricated fiber post, followed by a standardized composite core build-up and definitive crown restoration. Post space preparation, dentin conditioning, and cementation will follow a standardized step-by-step clinical protocol for each group.
The primary outcome is the post-gutta-percha gap distance, measured radiographically and expressed continuously in millimeters, with cases additionally classified as showing no gap versus any measurable gap. This dichotomization and its expected baseline distribution are informed by prior clinical data reporting outcomes in maxillary anterior teeth. The secondary outcome is post and restoration retention, evaluated clinically at follow-up using USPHS criteria.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mohamed elsayed Bekhiet, Master Degree
- Número de telefone: +201224238808
- E-mail: Mohamed.Bekhet@dentistry.cu.edu.eg
Locais de estudo
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Manial
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Cairo, Manial, Egito, 11553
- Faculty of Dentistry Cairo University
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Contato:
- Mohamed elsayed Bekhiet, master degree
- Número de telefone: +2.1224238808
- E-mail: Mohamed.Bekhet@dentistry.cu.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Endodontically treated maxillary anterior teeth (incisors and/or canines)
- Presence of 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction (CEJ)
- Remaining sound tooth structure meeting minimum ferrule criteria: wall height ≥1.5-2 mm and circumferential thickness ≈1 mm
- Adequate root canal filling with no radiographic signs of periapical pathology
- Root length and canal morphology suitable for post space preparation
- Patients aged 20-40 years
- Willing and able to provide informed consent and attend follow-up visits
Exclusion Criteria:
- Teeth with 3 or more missing coronal axial walls (insufficient ferrule)
- Evidence of active periapical pathology, root fracture, or root resorption
- Insufficient remaining root length for adequate post retention
- Signs of periodontal disease affecting tooth prognosis (e.g., mobility, inadequate periodontal support)
- Systemic conditions contraindicating routine dental treatment
- Pregnancy (if radiographic follow-up is required)
- Inability to attend scheduled follow-up visits
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 |
|---|---|
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Comparador Ativo: Prefabricated Fiber Post with Composite Core
Participants receive a prefabricated fiber post, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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Experimental: Custom-Fit UHMWPE Fiber Post with Composite Core
Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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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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Post-Gutta-Percha Gap Distance
Prazo: Immediately post-cementation (baseline)
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Distance between the outer surface of the cemented post and the residual root canal filling (gutta-percha), measured radiographically at the coronal, middle, and apical thirds of the post space.
Reported both as a continuous measurement (mm) and dichotomized as no gap versus any measurable gap.
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Immediately post-cementation (baseline)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post and Restoration Retention
Prazo: 6 months post-cementation
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Clinical retention of the post-core-crown restoration, assessed using United States Public Health Service (USPHS) criteria.
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6 months post-cementation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Mohamed labib zamzam, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
- Cadeira de estudo: omnia nabil, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
Publicações e links úteis
Publicações Gerais
- Moezizadeh M, Shokripour M. Effect of fiber orientation and type of restorative material on fracture strength of the tooth. J Conserv Dent. 2011 Oct;14(4):341-5. doi: 10.4103/0972-0707.87194.
- de Morais DC, Butler S, Santos MJMC. Current Insights on Fiber Posts: A Narrative Review of Laboratory and Clinical Studies. Dent J (Basel). 2023 Oct 10;11(10):236. doi: 10.3390/dj11100236.
- Naim H, Ahmad M, Ageeli AA, Abuarab RK, Sayed ME, Dewan H, Chohan H, Alshehri AH, Wadei MHDA, Alqahtani SM, Feroz SMA, Porwal A, Alshahrani AA. Radiographic Evaluation of the Gap between Cemented Post and Remaining Gutta-Percha in Endodontically Treated Teeth Performed by Undergraduate Students: A Retrospective Cross-Sectional Study. Medicina (Kaunas). 2023 Mar 3;59(3):502. doi: 10.3390/medicina59030502.
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
Outros números de identificação do estudo
- CEBD-CU-2025-07-29
Plano para dados de participantes individuais (IPD)
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