Tooth LossNCT06576284
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
An observational study of Tooth Loss and Dental Implant, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are: 1. Are these novel implants safe, effective, and clinically viable for 36 months? 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Dental Implant
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Oct 2024to Oct 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System
Who may be able to join
- Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase;
- Completed the 12-month follow-up period after implant placement in the previous interventional phase;
- Available for follow-up evaluations during the 36 months of the observational study.
Who cannot join
- Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase;
- Development of uncontrolled medical conditions during the follow-up period;
- Inability to attend scheduled follow-up visits;
- Refusal to participate in the observational study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Dentistry - University of São Paulo
São Paulo, 05508-900
Giuseppe A Romito, PhD, +55 11 30917833, garomito@usp.br
Marilia Gomes, +55 11 30917833, maricg@usp.br
About this study
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:
- Are these novel implants safe, effective, and clinically viable for 36 months?
- Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.
- Conditions
- Tooth Loss, Dental Implant
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Personalized implant | This is an observational, prospective, single-cohort study conducted at the University of São Paulo, São Paulo, Brazil, involving individuals who received a personalized dental implant using the iDENTICAL Dental Implant System. The aim is to evaluate the safety, efficacy, and clinical viability of these customized implants over a 36-month follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success
Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration.
Measured: 12 months, 24 months and 36 months
Secondary outcomes (3)
Linear horizontal changes of peri-implant soft tissues
measured from intraoral scans at 1mm, 3mm, and 5mm below the reference gingival margin level at the time of crown placement, at 12, 24, and 36 months.
Measured: 12 months, 24 months and 36 months
Prosthetic Level outomes
Chipping/fracture of material; Loss of retention of restoration (cementation cement fracture); Connector (Abutment) fracture; Loss/failure of restoration substrate requiring new restoration; The restoration functions as intended/satisfactorily for the subject
Measured: 12 months, 24 months and 36 months
Peri-implant clinical parameters
Mobility (MOB)
Measured: 12 months, 24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start2 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Alexandre Romito, University of Sao Paulo
- Investigators
- Giuseppe A Romito, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576284
- Sponsor's protocol ID
- 6.987.078
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
- ClinicalTrials.gov ID
- NCT06576284
- Acronym / sponsor ID
- 6.987.078
- Conditions
- Tooth Loss, Dental Implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Aug 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.
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:
- Are these novel implants safe, effective, and clinically viable for 36 months?
- Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized implant | – | –This is an observational, prospective, single-cohort study conducted at the University of São Paulo, São Paulo, Brazil, involving individuals who received a personalized dental implant using the iDENTICAL Dental Implant System. The aim is to evaluate the safety, efficacy, and clinical viability of these customized implants over a 36-month follow-up period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System
Key inclusion criteria (3 listed)
- Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase;
- Completed the 12-month follow-up period after implant placement in the previous interventional phase;
- Available for follow-up evaluations during the 36 months of the observational study.
Key exclusion criteria (4 listed)
- Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase;
- Development of uncontrolled medical conditions during the follow-up period;
- Inability to attend scheduled follow-up visits;
- Refusal to participate in the observational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic success
Time frame: 12 months, 24 months and 36 months
Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration.
3 secondary outcomes
Linear horizontal changes of peri-implant soft tissues
Time frame: 12 months, 24 months and 36 months
Prosthetic Level outomes
Time frame: 12 months, 24 months and 36 months
Peri-implant clinical parameters
Time frame: 12 months, 24 months and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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.
Giuseppe A Romito, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Dental Implant, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romito ((11) 992051939 ext. +55, garomito@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic success (time frame: 12 months, 24 months and 36 months). 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 20 Nov 2024.