Prosthetic ComplicationNCT06745232
New Stereophotogrammetry System to Capture Complete-arch Impression
An observational study of Prosthetic Complication and Prosthesis Failure, Dental, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Complication, Prosthesis Failure, Dental
- What is being tested?
- FAST MAP
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to 1 Aug 2025
- How long will I take part?
- 3 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: Patients in need of complete arch rehabilitations with dental implants and fixed dental prosthesis
Who may be able to join
- Healthy patients aged ≥18 years
- Full mouth bleeding and full mouth plaque index lower than or equal to 25%
- Bone height for at least 10 mm long implants
- Bone width of at least 5 mm and 6 mm for narrow (NP 3.75/3.5 mm) and regular (RP 4.3 mm) implants, respectively
- Fresh extraction sockets with an intact buccal wall
- At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla
- Minimal insertion torque of 45 Ncm
Who cannot join
- General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
- Pregnancy and/or breastfeeding
- Any interfering medication such as steroid therapy or bisphosphonate therapy
- Alcohol and/or drug abuse
- Heavy smoking (>10 cigarettes/day)
- Radiation therapy to head or neck region within 5 years
Show all 11Show fewer
- Untreated periodontitis
- Acute and chronic infections of the adjacent tissues or natural dentition
- Severe maxillomandibular skeletal discrepancy
- High and moderate parafunctional activity
- Absence of opposite teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
PTV
Roma, RM, 00133
Paolo Carosi, PhD, paolo.carosi@alumni.uniroma2.eu
About this study
Official title: The Use of a New Stereophotogrammetry System to Capture Intra-operative Complete-arch Impression
Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis
- Being tested
- FAST MAP
- Keywords
- fixed prosthesis, stereophotogrammetry, immediate loading
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST MAPDevice
Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression
| Study group | Role | What they receive |
|---|---|---|
| FAST MAP | Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression Receives: Device: FAST MAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Success
Prosthetic success of interim prosthesis in term of passivity and tissues adaptability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start10 Jan 2025
- Primary completion25 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic ComplicationStudies 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
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Carosi, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745232
- Sponsor's protocol ID
- FASTMAPPROSPECTIVE
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a New Stereophotogrammetry System to Capture Intra-operative Complete-arch Impression
- ClinicalTrials.gov ID
- NCT06745232
- Acronym / sponsor ID
- FASTMAPPROSPECTIVE
- Keywords
- fixed prosthesis, stereophotogrammetry, immediate loading
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Dec 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.
Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAST MAP | – | Device: FAST MAPPatients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in need of complete arch rehabilitations with dental implants and fixed dental prosthesis
Key inclusion criteria (7 listed)
- Healthy patients aged ≥18 years
- Full mouth bleeding and full mouth plaque index lower than or equal to 25%
- Bone height for at least 10 mm long implants
- Bone width of at least 5 mm and 6 mm for narrow (NP 3.75/3.5 mm) and regular (RP 4.3 mm) implants, respectively
- Fresh extraction sockets with an intact buccal wall
Key exclusion criteria (11 listed)
- General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
- Pregnancy and/or breastfeeding
- Any interfering medication such as steroid therapy or bisphosphonate therapy
- Alcohol and/or drug abuse
- Heavy smoking (>10 cigarettes/day)
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 |
|---|---|---|
| FAST MAPPatients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression | Device | FAST MAP |
Primary outcome
Prosthetic Success
Time frame: 3 months
Prosthetic success of interim prosthesis in term of passivity and tissues adaptability
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 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 Prosthetic Complication and Prosthesis Failure, Dental, run by University of Rome Tor Vergata at 1 site in Italy.
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 7 inclusion and 11 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 7 Mar 2025. 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 Italy. 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 Paolo Carosi, PhD (327798699 ext. +39, paolo.carosi@alumni.uniroma2.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Success (time frame: 3 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 7 Mar 2025.