Success and Safety of the Implant Placement Using Navigated Surgery

NCT06669286 | Not Yet Recruiting

• 1 other identifier: ClinicaOdontoiatricaVilla
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edentulism

Keywords

navigated surgery; alveolar nerve; implant placement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety assessment with focus on alveolar nerve

  1 year

Interventions

implant placement using navigated surgery near alveolar nerve PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• year follow-up data on treatment success not available

Sponsors & Collaborators

• Roberto Villa: lead
• Nobel Biocare Services AG: collaborator

Central Study Contacts

Roberto Villa

CONTACT

+39 015 352481; r.villa@clinicavilla.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: November 1, 2024
• Study Start: December 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10