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临床试验/NCT07727980
NCT07727980尚未招募不适用

Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing Abutment

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Three-dimensional (3D) peri-implant soft tissue volumetric changes within the region of interest (ROI)

研究概览

简要总结

The goal of this clinical trial is to evaluate whether an anatomical prefabricated healing abutment (AHA) improves tissue preservation and clinical outcomes following immediate implant placement after tooth extraction in adults. Although immediate implant placement is a well-established treatment for replacing missing teeth, healing can result in changes to the surrounding bone and soft tissues that may affect the esthetic appearance, function, and long-term stability of the implant-supported restoration. This study will compare an anatomical healing abutment, designed to mimic the natural tooth emergence profile and support peri-implant tissues during healing, with a conventional healing abutment. The primary objectives are to determine whether the AHA better preserves soft tissue contours and alveolar bone, improves implant positioning accuracy and tissue stability during healing, and differs from a conventional healing abutment in complications or adverse events. Eligible participants will be adults requiring extraction of a hopeless tooth in the posterior maxilla or mandible who are suitable candidates for immediate implant placement. Following tooth extraction and implant placement, participants will receive either an anatomical prefabricated healing abutment or a conventional healing abutment and will return for scheduled follow-up visits over approximately 12 months to assess healing, implant stability, and changes in the surrounding hard and soft tissues. Researchers will collect clinical measurements, digital intraoral scans, photographs, and radiographic images throughout the study. Additional research imaging will be used to generate three-dimensional models to measure tissue volume changes and implant position accuracy. Specialized software will compare changes between the two groups over time. Safety will be evaluated by monitoring participants for complications, discomfort, inflammation, implant-related problems, and other adverse events throughout follow-up. All procedures will be performed by trained dental professionals using established clinical protocols. The results may improve understanding of how healing abutment design influences tissue preservation after immediate implant placement and help optimize future implant therapy by supporting better functional, esthetic, and long-term outcomes.

详细描述

Immediate replacement of a severely damaged posterior tooth with a dental implant has demonstrated high long-term success rates while offering the advantages of shorter treatment time and fewer invasive procedures compared with delayed implant placement. Beyond successful osseointegration, preservation of healthy peri-implant soft tissue and development of an optimal emergence profile are critical determinants of long-term implant success, as they reduce food impaction and plaque accumulation, facilitate oral hygiene, and contribute to favorable esthetic and functional outcomes. Historically, conventional healing abutments have been used primarily during the uncovering phase to promote soft-tissue healing; however, their cylindrical design does not replicate the natural contour of the extracted tooth and provides limited support for peri-implant soft-tissue architecture. Consequently, clinicians often use temporary titanium abutments and composite resin to customize healing abutments, or fabricate provisional restorations to shape the soft tissues during healing.

Recent evidence suggests that customized healing abutments, which mimic the natural tooth morphology, particularly in the cervical third, may better preserve peri-implant soft tissue contours, maintain marginal bone height, reduce early loading of immediately placed implants, and facilitate the development of a natural prosthetic emergence profile. Conventional customization with composite resin on a temporary abutment is technique-sensitive, requires additional clinical time, and carries the risk of contamination of the extraction socket by excess composite material. Prefabricated scannable AHAs have been developed to overcome these limitations by conforming to the extraction socket anatomy, supporting the surrounding soft tissues to prevent collapse during healing, stabilizing the blood clot, preserving space for bone regeneration, and simultaneously functioning as scan bodies for digital impression workflows. In addition, AHAs accurately transfer the three-dimensional implant position, potentially reducing treatment time, minimizing complications associated with repeated component exchanges, improving patient comfort and satisfaction, and streamlining fabrication of the definitive implant-supported restoration.

Preliminary laboratory investigations, clinical case reports, and early prospective clinical studies support the feasibility of AHAs for soft tissue management and digital implant workflows. However, the current evidence remains limited, particularly regarding their effectiveness in preserving pre-extraction soft-tissue contours following immediate implant placement in posterior sites. Existing studies are characterized by relatively small sample sizes, heterogeneous methodologies, and limited longitudinal clinical data. Therefore, further clinical investigation is needed to determine whether scannable anatomical healing abutments provide measurable benefits over conventional approaches in preserving peri-implant soft-tissue architecture and optimizing the emergence profile prior to the fabrication of a definitive single-implant-supported crown. This study aims to compare the anatomical healing abutment's capacity to preserve preextraction soft tissue contours, with attention to the position of the mid-facial gingival margin, enabling the delivery of the final crown in a shorter treatment period without the need for further soft tissue conditioning. The findings of this study will address an important gap in the literature and contribute to evidence-based protocols for immediate implant therapy and digital restorative workflows.Despite these theoretical and practical advantages, the currently available scientific literature remains relatively limited. Existing investigations primarily consist of laboratory studies, technical reports, case series, retrospective analyses, and a limited number of prospective clinical investigations. Although preliminary findings suggest favorable soft tissue management, simplified digital workflows, and acceptable clinical outcomes, robust randomized controlled clinical trials directly comparing Anatomical Healing Abutments with conventional healing abutments remain scarce. The available literature is further limited by relatively small sample sizes, heterogeneous methodologies, short observation periods, and inconsistent outcome measures.

Additional randomized clinical investigations using standardized surgical protocols, digital outcome measurements, validated esthetic indices, radiographic analyses, patient-reported outcomes, and longitudinal follow-up are needed to establish evidence-based recommendations regarding their clinical effectiveness.

The present study has been designed to address this important knowledge gap. The primary purpose of this multicenter randomized controlled clinical trial is to determine whether a prefabricated scannable Anatomical Healing Abutment provides superior preservation of peri-implant soft tissue contours compared with a conventional titanium healing abutment following immediate implant placement in posterior extraction sites. Rather than focusing exclusively on implant survival, the investigation comprehensively evaluates biological, prosthetic, radiographic, esthetic, digital, patient-centered, and economic outcomes throughout one year of functional loading.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Surgeon

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to sign an IRB-approved informed consent and HIPAA authorization form prior to participation.
  • Between the ages of 20 and 75 years old.
  • ASA Classification I and II.
  • Hopeless maxillary or mandibular posterior teeth, eligible for immediate implantation, and with intact/successfully restored adjacent teeth.
  • Willing to perform tasks associated with the study and to attend all study visits.

排除标准

  • HbA1c >6.5%) as per a chairside test (Siemens Bayer DCA 2000+);
  • smoker (any status);
  • immunodeficiency;
  • history of head and neck radiotherapy;
  • intake of bone anti-resorptive drugs;
  • cysts or tumors in the area;
  • self-reported pregnancy;
  • poor oral hygiene;
  • active periodontal disease;
  • acute endodontic infection and pus discharge on the site itself and adjacent areas;
  • lack of mutually protected occlusion;
  • insufficient inter-occlusal clearance (<15 mm);
  • sites with an existing midfacial mucogingival recession/deficiency (scar tissue);
  • sites with a high-scalloped, thin biotype.
  • Those who appear to qualify will have a CBCT scan taken with an open bite and proper retractions of the cheek, lips, and tongue (standard of care), and the following inclusion criteria, based on the CBCT results, must be present in order for the subject to be fully enrolled in the study:
  • Sites with an intact or minimally damaged facial bone plate measuring greater than 1 mm in thickness;
  • Sites with at least 5 mm of healthy bone between the socket apex and the relevant anatomical structure (e.g., the maxillary sinus floor in the maxilla or the inferior alveolar nerve, submandibular/sublingual fossa, mental foramen, or anterior loop of the inferior alveolar nerve in the mandible);
  • In multirooted molar sockets, the presence of a short root trunk and an interradicular septum with a minimum height of 5 mm and a thickness of 3 mm.

结局指标

主要结局

Three-dimensional (3D) peri-implant soft tissue volumetric changes within the region of interest (ROI)

时间窗: From enrollment to the end of treatment at 12 months follow-up

To assess soft tissue three-dimensional (3D) volumetric changes by calculating the percentage variation in cubic millimeters (% mm³) within defined regions of interest (ROI), using superimposed consecutive digital surface models (intraoral scans) obtained at pre-extraction (T1), impression (T3), baseline/prosthesis delivery (T4), 6 months (T5), and 12 months (T6), at the Geomagic® metrology software. This endpoint will assess the ability of the scannable anatomical healing abutment to preserve peri-implant soft tissue contours following immediate implant placement. Longitudinal changes will be analyzed using mixed-effects models to evaluate the interaction between treatment group and time.

次要结局

  • Mid-facial mucosal margin (MM) level(From enrollment to the 12-months follow-up)
  • Keratinized mucosa width (KMW)(From enrollment to 12-months follow-up)
  • Pink Esthetic Score (PES)(From prosthesis delivery to 12-months follow-up)
  • Implant position accuracy(From implant planning to immediate post-implant placement)
  • 3D hard tissue change (3DHT)(From implant placement to 12-months follow-up)
  • Marginal Bone Level (MBL)(From implant placement to 12-months follow-up)
  • Implant survival rate (SR)(From implant placement to 12-months follow-up)
  • Peri-implant Tissue Health Status(From loading (prosthesis delivery) to the 12-months follow-up)
  • Insertion Torque(Perioperative (at T3 - Implant Placement))
  • Biological Complications(From prosthesis delivery to the 12-months follow-up)
  • Implant Stability(Perioperative and at Day 90 (T4 - Implant Impression))
  • Prosthetic Complications(From prosthesis delivery to the 12-months follow-up)
  • Patient-Related Outcome Measures (PROMs) - Oral Health-Related Quality of Life (OHRQoL)(From prosthesis delivery to the 12-months follow-up)
  • Patient-Related Outcome Measures (PROMs) - Patient's Satisfaction as assessed through a Visual Analogue Scale (VAS)(At 6- and 12- months follow-up only)
  • Clinical Time(At implant placement & Prosthesis delivery)
  • Laboratory Time(From implant placement to prosthesis delivery)
  • Direct Costs(From implant placement to prosthesis delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Mezzomo

Clinical Associate Professor

University of Illinois at Chicago

研究点 (2)

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