Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes (IMPLA-CHA)
31 de agosto de 2026 atualizado por: Plovdiv Medical University
Evaluation of the Success of Immediate Implants in the Molar Region Using Individually Fabricated Healing Abutments (Sulcus Formers) in Different Classes of Post-Extraction Sockets: A Prospective Cohort Study
Immediate implant placement into a fresh extraction socket shortens overall treatment time and reduces the number of surgical procedures, but the fit between the implant and the socket walls, and the resulting soft-tissue contour, differ substantially between socket types. This study evaluates immediate implant placement in the molar and posterior region combined with an individually fabricated (customized) healing abutment, or sulcus former, that seals the socket and shapes the emergence profile from the day of surgery.
Consecutive patients with a non-restorable posterior tooth are treated with flapless atraumatic extraction, immediate implant placement, grafting of the residual gap, and a chairside customized healing abutment fabricated on a titanium temporary abutment. Participants are grouped by the class of the post-extraction socket (A, B or C) according to the interradicular septal bone available for primary stability.
Outcomes are preservation of peri-implant soft-tissue volume assessed with an intraoral scanner, preservation of alveolar bone volume assessed on cone-beam computed tomography, implant stability measured by resonance frequency analysis (ISQ) at placement and before loading, and time to definitive loading. Early wound healing on the Landry index, the degree of bone corticalization before loading, implant survival, healing-abutment complications and analgesic requirement are also recorded.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
60
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.
Contato de estudo
- Nome: Lyubomir Chenchev, DMD, PhD
- Número de telefone: +359 887 102 516
- E-mail: lyubomir.chenchev@mu-plovdiv.bg
Locais de estudo
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Plovdiv, Bulgária, 4000
- Recrutamento
- Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv
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Contato:
- Lyubomir Chenchev, DMD, PhD
- Número de telefone: +359 887 102 516
- E-mail: lyubomir.chenchev@mu-plovdiv.bg
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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
Método de amostragem
Amostra Não Probabilística
População do estudo
Consecutive adult patients attending the Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv, with a non-restorable posterior (premolar or molar) tooth indicated for extraction and suitable for immediate implant placement.
Descrição
Inclusion Criteria:
- Age 18 years or over
- ASA physical status I or II
- A non-restorable posterior tooth (premolar or molar) indicated for extraction: clinically unrestorable crown, advanced chronic periodontitis, failed or untreatable endodontic therapy, or vertical root fracture
- Residual bone permitting implant placement with adequate primary stability
- Able and willing to give written informed consent and to attend the follow-up schedule
Exclusion Criteria:
- ASA physical status III or higher
- Pregnancy or lactation
- Uncontrolled diabetes mellitus
- Smoking more than 10 cigarettes per day
- Drug or alcohol abuse
- Current or previous bisphosphonate or other antiresorptive therapy
- Head and neck radiotherapy
- Immunosuppression
- Anticoagulant or antiplatelet therapy where the required pre-operative preparation is declined
- Psychiatric conditions preventing compliance with the study procedures
- Known titanium allergy
- Severe bruxism
- Acute infection at the surgical site
- Advanced alveolar resorption precluding immediate implant placement
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Socket class A
Posterior extraction socket in which the interradicular septal bone is sufficient to house the implant, giving circumferential bone contact along its coronal part.
Because a molar socket is frequently 10 mm or more across, a residual void commonly remains around the implant within the socket.
Participants receive immediate implant placement with a chairside customized healing abutment.
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Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
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|
Socket class B
Posterior extraction socket in which the septal bone is sufficient to stabilise the implant but not to house it, so that part of the implant surface faces the socket rather than bone.
Participants receive immediate implant placement with a chairside customized healing abutment.
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Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
|
|
Socket class C
Posterior extraction socket with little or no septal bone, so that primary stability must be obtained from the peripheral socket walls and/or the bone apical to the socket.
Participants receive immediate implant placement with a chairside customized healing abutment.
|
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in peri-implant soft-tissue volume
Prazo: Baseline, 3 months after placement (before loading), and 2 weeks after loading
|
Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans.
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Baseline, 3 months after placement (before loading), and 2 weeks after loading
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Time to definitive loading
Prazo: Up to 6 months after implant placement
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Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient.
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Up to 6 months after implant placement
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Implant stability quotient (ISQ)
Prazo: At implant placement and at 3 months after placement (before loading)
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Implant stability measured by resonance frequency analysis on the ISQ scale from 1 to 100, where higher values indicate greater stability.
Stability before loading is the criterion that determines whether the implant is loaded at three months.
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At implant placement and at 3 months after placement (before loading)
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Change in alveolar bone volume
Prazo: Baseline and 3 months after placement (before loading)
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Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography.
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Baseline and 3 months after placement (before loading)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Early wound healing
Prazo: Days 7 and 14 after surgery
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Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.
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Days 7 and 14 after surgery
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Analgesic requirement
Prazo: First 5 days after surgery
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Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.
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First 5 days after surgery
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Customized healing abutment complications
Prazo: From surgery to definitive loading, up to 4 months
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Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent.
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From surgery to definitive loading, up to 4 months
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Implant survival
Prazo: Up to 24 months after implant placement
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Proportion of implants in situ and functional at the latest follow-up visit.
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Up to 24 months after implant placement
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Peri-implant bone corticalization
Prazo: 3 months after placement (before loading)
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Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index.
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3 months after placement (before loading)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Tasho Gavrailov, DMD, PhD, Medical University of Plovdiv
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)
1 de abril de 2024
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
31 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de agosto de 2026
Primeira postagem (Real)
3 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NO-18/2025
- R-KNE-55/10.11.2025 (Outro identificador: Committee on Scientific Ethics, Medical University of Plovdiv)
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 made publicly available.
De-identified data supporting the published analyses are available from the corresponding author on reasonable request.
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 .