Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06669286

Success and Safety of the Implant Placement Using Navigated Surgery

Subjects with severely atrophic mandibles were treated with implants and implant-based restorations. Subjects will be required to consent to study participation and data processing according to General Data Protection Regulation (GDPR). Implant positions were planned digitally in a dental software DTX Studio, and implants placed with navigated surgery (Nobel Biocare X-Guide). Implants eligible for this study must be placed 2 mm or less from the alveolar nerve. Implants placed are NobelParallel TiUnite and NobelActive TiUnite. All subjects were followed up for 1 year after surgery to monitor success and adverse events related to the alveolar nerve. Data analysis will include demographics, medical history, Cone-beam Computed Tomography (CBCT) scans/peri-apical x-ray data, soft tissue parameters, and adverse events.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study aims to evaluate the success and safety of immediate navigated implant placement in the atrophic mandible or post-extraction sockets near the alveolar nerve, as an alternative to guided bone regeneration followed by delayed implant placement.

This single-center retrospective study includes 20 subjects with severely atrophic mandibles or post-extraction sockets, followed for 1 year after implant placement.

The primary objective is to assess treatment success, defined as the implant supporting a dental prosthesis, no adverse events related to the alveolar nerve, and minimal bone loss around the implant. The secondary objective focuses on safety, particularly concerning the alveolar nerve. Subjects must meet specific inclusion criteria, such as implants placed within 2 mm of the alveolar nerve and being at least 18 years old and must have signed consent forms. Exclusion criteria include the absence of 1-year follow-up data.

Data collected includes demographic and medical history, plaque, bleeding, and gingival indices at pre-treatment and 1-year follow-up, and radiographic exams (CBCT and intra-oral radiographs) to assess bone levels. Written informed consent is required, and all data is de-identified and transferred to Switzerland for analysis, complying with EU regulations. This study aims to provide a less invasive alternative to traditional methods, potentially reducing the number of surgical interventions needed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Implants placed in 2 mm distance or less of the alveolar nerve
  • Subject was at least 18 years old at the time of surgery
  • Subject signed consent form
  • Subject signed GDPR form

Exclusion criteria

  • 1-year follow-up data on treatment success not available

Treatment and study plan

implant placement using navigated surgery near alveolar nerve

Procedure

Dental implant placement in proximity of alveolar nerve (within 2 mm) using navigated surgery.

Primary outcomes

  1. Treatment success after 1 year of implant placement

    Time frame: 1 year

    Treatment success is defined specific to this study as:

    • The implant supports a dental prosthesis
    • No adverse event related to the alveolar nerve
    • No or only minor bone loss around the implant

Secondary outcomes

  1. Safety assessment with focus on alveolar nerve

    Time frame: 1 year

    The safety of the procedure will be evaluated based on the data collected from the adverse events and device deficiency issues. Based on the seriousness of the event it is categorized as either:

    • Adverse Event (AE)
    • Serious Adverse Event (SAE)• Adverse Device Effect (ADE) Serious Adverse Device Effect (SADE)
    • Unanticipated Serious Adverse Device Effect (USADE)
    • Device Deficiency (DD) Known issues associated with dental implant surgery include, but are not limited to, excessive bleeding during surgery, pain, alveolar wall fracture, partial or total anesthesia after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Villa

CONTACT

[email protected]

+39 015 352481

Sponsors and collaborators

Lead sponsor

Roberto Villa

Other

Collaborators

  • Nobel Biocare Services AG

Registry information

Official study title

Retrospective Single Cohort Mono-center Study on Success and Safety of Navigated Implant Placement in Proximity of the Alveolar Nerve

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.