Surgical Robot or Static Guide for Dental Implant Placement
5 de maio de 2026 atualizado por: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Comparison of Robotic and Static Guide Assisted Surgery for Rehabilitation of Monolateral Distal Extension Edentulism With Implant-supported Fixed Partial Dentures: a Multicenter Randomized Controlled Trial.
Precision in implant placement is a key requirement for safety and to support the long-term success of dental implants.
Optimal placement requires implementing a diagnostic standard that includes careful digital planning based on CBCT and intraoral scanning data.
Once the case is planned, adherence to the plan during surgery cannot be achieved through freehand surgery; guidance is needed.
Guidance has two key components: real-time tracking of osteotomy site preparation (achieved with dynamic navigation technology) and constraining instrumentation to the planned site (achieved through the application of a surgical template that guides the position and direction of bone drilling).
Robotic surgery enables both objectives: real-time monitoring and guidance.
Previous studies have shown high precision for both static guidance and robotic surgery, but the evidence is limited to a few small-sample-size studies, mostly in single-tooth gap applications.
Evidence of the applicability of the technologies to more challenging clinical conditions, such as the more complex distal extension, is lacking.
In addition, so far, dental implant robotics studies have focused only on metrics of implant placement precision and have failed to capture a broader context that may be equally important for clinical decision-making and patient preferences.
In this respect, it is important to emphasize the recent implant dentistry core outcome set and measurement (ID-COSM) framework that mandates capturing and reporting a full range of outcomes across multiple domains.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
112
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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SH
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Shanghai, SH, China, 201206
- International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
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Contato:
- Yuan Li, PhD
- Número de telefone: 8615000102368
- E-mail: ly9919@hotmail.com
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Shanxi
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Xi’an, Shanxi, China
- Center for Robotic Dentistry, Airforce University Medical Hospital
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Contato:
- Shizhu Bai, PhD
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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:
- Age ≥ 18 years
- Monlateral distal free-end edentulism
- Presence of natural teeth or reliable fixed restorations mesial to the edentulous area to provide support and stability for the surgical guide
- Preoperative CBCT assessment shows available bone height ≥8 mm and bone width ≥5 mm in the edentulous area, allowing implant placement without concomitant complex bone augmentation
Exclusion Criteria:
- Uncontrolled periodontitis or acute oral infection
- Uncontrolled systemic diseases (e.g., diabetes, severe osteoporosis) or pregnancy/lactation
- History of head and neck radiotherapy or current use of intravenous bisphosphonates
- Severe limited mouth opening (interincisal distance <35 mm) affecting surgical instrument manipulation
- Psychiatric or psychological disorders that prevent cooperation with study procedures
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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Experimental: Robot assisted dental implant placement surgery
Novel robotic implant placement
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The test intervention will comprise autonomous dental implant placement using the YakeRobot.
The 3Shape treatment planning will be exported into the YakeRobot software for robotic planning and the robotic planning will be finalized.
Two Straumann implants will be positioned to retain a bridge, following the standard YakeRobot implant placement procedure.
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Comparador Ativo: 3D printed static guide assisted dental implant placement surgery
standard of care
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The control intervention will consist of guided implant surgery with a static guide, planned using the 3Shape software and custom 3D-printed following the international standard of best practice.
Two Straumann implants will be positioned to retain a bridge, following the Straumann guided surgery placement protocol.
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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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Degrees of Implant misangulation
Prazo: 3 months after implant surgery
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The implant position was acquired 3 months after implant surgery with an intraoral scan (TRIOS 3; 3Shape) with a scan body in place.
The actual position was compared with the digital plan by the accuracy analysis software (DentalNavi 2.2; YakeRobot Technology Ltd) by an independent calibrated examiner blind to group allocation.
The discrepancy between planned and actual implant axis angulation will be measured in degrees.
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3 months after implant surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Implant positioning error
Prazo: 3 months after implant surgery
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Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
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3 months after implant surgery
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Food Frequency Questionnaire (FFQ)
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Dietary intake assessed using a validated Food Frequency Questionnaire that calculates the long term dietary intake in grams of the different food types
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Health-Related Quality of Life (OHIP-14)
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral health-related quality of life measured by the OHIP-14 questionnaire (14 items), using a 5-point Likert scale with Higher scores indicate poorer quality of life.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Rinse Sample Microbiome
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Collection of oral rinse fluid for analysis of microbiome
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Stool Metagenome
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Fecal sample collection for gut microbiome analysis using a metagenomic approach.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Blood Sample
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Venous blood will be collected and processed to obtain plasma.
Plasma samples will be analyzed using metabolomics profiling to assess metabolic changes associated with the intervention.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Masticatory Function
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Masticatory performance is assessed using a two-color chewing gum test.
Participants chew a dual-color gum (e.g., blue and red) for a standardized number of cycles.
The degree of color mixing is evaluated by image analysis, providing an objective measure of chewing efficiency.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Postoperative Diary (First 2 Weeks)
Prazo: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
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Patient-recorded daily symptoms including pain (0-10 scale), swelling, analgesic use, bleeding, and any unusual events during the first 14 days after surgery.
Diary is collected at the 2-week suture removal visit.
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From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
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Clinician-Reported Outcomes
Prazo: Immediately after surgery.
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Surgeon-reported outcomes assessed immediately after surgery, including: surgical difficulty (e.g., VAS), intraoperative complications, calibration issues, need for conversion to freehand, and overall procedural success.
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Immediately after surgery.
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Treatment Planning and Surgical Procedure Times
Prazo: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
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Composite of two time-based efficiency measures: (1) preoperative digital planning time (minutes), and (2) total surgical procedure time from incision to final suture (minutes).
Both are recorded separately.
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Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
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Implant-Supported Restoration Examination
Prazo: 3 months after prothesis delivery; 12 months after prothesis delivery.
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Multidimensional clinical assessment of implants and prostheses following the ID-COSM (implant dentistry core outcome set and measurement)
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3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Rinse Sample Inflammation
Prazo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Collection of oral rinse fluid for analysis of inflammatory markers
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Investigadores
- Investigador principal: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publicações e links úteis
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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 (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
31 de julho de 2027
Conclusão do estudo (Estimado)
30 de outubro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
11 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- SH9H-2026-T177-2
- JYXK-2026-047 (Número de outro subsídio/financiamento: Shanghai Ninth People's Hospital)
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INDECISO
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