EdentulismNCT06669286
Success and Safety of the Implant Placement Using Navigated Surgery
An observational study of Edentulism, run by Roberto Villa.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism
- What is being tested?
- implant placement using navigated surgery near alveolar nerve
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 1-year follow-up data on treatment success not available
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- implant placement using navigated surgery near alveolar nerve
- Keywords
- navigated surgery, alveolar nerve, implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement using navigated surgery near alveolar nerveProcedure or surgery
Dental implant placement in proximity of alveolar nerve (within 2 mm) using navigated surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start31 Dec 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roberto Villa
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare Services AG
- Responsible party
- Sponsor-investigator, Roberto Villa, Clinica Odontoiatrica Villa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669286
- Sponsor's protocol ID
- ClinicaOdontoiatricaVilla
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Single Cohort Mono-center Study on Success and Safety of Navigated Implant Placement in Proximity of the Alveolar Nerve
- ClinicalTrials.gov ID
- NCT06669286
- Acronym / sponsor ID
- ClinicaOdontoiatricaVilla
- Conditions
- Edentulism
- Keywords
- navigated surgery, alveolar nerve, implant placement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Roberto VillaUniversity, hospital or other
- Collaborators
- Nobel Biocare Services AG
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1-year follow-up data on treatment success not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant placement using navigated surgery near alveolar nerveDental implant placement in proximity of alveolar nerve (within 2 mm) using navigated surgery. | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Safety assessment with focus on alveolar nerve
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism, run by Roberto Villa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Villa (+39 015 352481, r.villa@clinicavilla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success after 1 year of implant placement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.