Success and Safety of the Implant Placement Using Navigated Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Edentulism
• Intervention / Treatment: Procedure: implant placement using navigated surgery near alveolar nerve

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Roberto Villa; Phone Number: +39 015 352481; Email: r.villa@clinicavilla.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Consecutive adult subjects (18 years) treated at the investigator's private practice for severely atrophic sites or post-extraction sites (single tooth to max. 4 teeth) in the mandible with navigated surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success after 1 year of implant placement	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment with focus on alveolar nerve	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.	1 year

Collaborators and Investigators

• Sponsor: Roberto Villa
• Collaborators: Nobel Biocare Services AG

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: implant placement; navigated surgery; alveolar nerve
• Other Study ID Numbers: ClinicaOdontoiatricaVilla

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No