Success and Safety of the Implant Placement Using Navigated Surgery

NCT ID: NCT06669286

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-07-30

Brief Summary

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.

Detailed Description

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.

Conditions

Edentulism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

implant placement using navigated surgery near alveolar nerve

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobel Biocare Services AG

UNKNOWN

Sponsor Role: collaborator

Roberto Villa

OTHER

Sponsor Role: lead

Responsible Party

Roberto Villa

dentist

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Roberto Villa

Role: CONTACT

r.villa@clinicavilla.com

+39 015 352481

Other Identifiers

ClinicaOdontoiatricaVilla

Identifier Type: -

Identifier Source: org_study_id