Alterações dos Tecidos Duros e Moles Peri-Implante Após Colocação Imediata do Implante com Socket Shield e Restauração Imediata versus Colocação Precoce do Implante na Zona Estética
Avaliação das Alterações dos Tecidos Duros e Moles Peri-implante entre a Colocação Imediata de Implante com Técnica de Escudo Alveolar e Restauração Imediata versus Colocação de Implante Tipo II Precoce na Zona Estética - Um Ensaio Clínico Controlado Randomizado
This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.
This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.
Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:
Test group: Immediate implant placement with socket shield technique and immediate restoration.
Control group: Early implant placement following soft tissue healing with contour augmentation.
Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ajman Emirate
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Ajman, Ajman Emirate, Emirados Árabes Unidos, 4184
- Gulf Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults aged 18 years or older
- Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
- Presence of a thin buccal bone plate (<1 mm)
- Adequate bone volume to allow implant placement in a prosthetically ideal position
- Intact socket walls following tooth extraction
- Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
- Patients willing to participate in the study and able to provide written informed consent
Exclusion Criteria:
- History of systemic diseases that may affect bone healing
- Use of medications that may influence bone metabolism (e.g., bisphosphonates)
- Smoking within the past 5 years
- Presence of acute infection at the surgical site or adjacent teeth
- Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
- Presence of internal or external root resorption
- Severe periodontal destruction at the implant site
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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Experimental: Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech
Participants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes. |
mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months
Outros nomes:
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Comparador Ativo: Early Type II Implant placement with Contour augmentation with Xenograft
Participants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes. |
atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration
Outros nomes:
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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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Pink Esthetic Score (PES)
Prazo: 12 months after implant restoration
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Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome. |
12 months after implant restoration
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Peri-implant Mid-facial Mucosal Recession
Prazo: 12 months after implant placement
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Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position. |
12 months after implant placement
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Horizontal Radiographic Peri-implant Bone Changes
Prazo: 12 months after implant Restoration
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Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling. |
12 months after implant Restoration
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Vertical Radiographic Peri-implant Bone Changes
Prazo: 12 months after implant Restoration
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Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling. |
12 months after implant Restoration
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Patient Satisfaction
Prazo: 12 months after implant restoration
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Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction. |
12 months after implant restoration
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Mohamed Atef Sayed, Ph.D., Assistant Professor of Periodontics
- Investigador principal: Moheb Silwadi, M.D.S, Gulf Medical University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- IRB-COD-STD-87-Feb-2025
- IRB-COD-STD-87-Feb-2025 (Outro identificador: Gulf Medical University)
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