Success and Safety of the Implant Placement Using Navigated Surgery

ConditionEdentulism

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorRoberto Villa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

Time frame

1 year

Secondary outcomes

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.

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roberto Villa

Lead sponsor

Clinica Odontoiatrica Villa

Sponsor institution

Nobel Biocare Services AG

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: