New Stereophotogrammetry System to Capture Complete-arch Impression

NCT ID: NCT06745232

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Prosthetic Complication Prosthesis Failure, Dental

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FAST MAP

Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression

FAST MAP

Intervention Type DEVICE

Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression

Interventions

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FAST MAP

Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Healthy patients aged ≥18 years
2. Full mouth bleeding and full mouth plaque index lower than or equal to 25%
3. Bone height for at least 10 mm long implants
4. 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
5. Fresh extraction sockets with an intact buccal wall
6. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla
7. Minimal insertion torque of 45 Ncm

Exclusion Criteria

1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
2. Pregnancy and/or breastfeeding
3. Any interfering medication such as steroid therapy or bisphosphonate therapy
4. Alcohol and/or drug abuse
5. Heavy smoking (\>10 cigarettes/day)
6. Radiation therapy to head or neck region within 5 years
7. Untreated periodontitis
8. Acute and chronic infections of the adjacent tissues or natural dentition
9. Severe maxillomandibular skeletal discrepancy
10. High and moderate parafunctional activity
11. Absence of opposite teeth
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Paolo Carosi

Post-doc Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PTV

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Carosi, PhD

Role: CONTACT

327798699 ext. +39

Facility Contacts

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Paolo Carosi, PhD

Role: primary

Other Identifiers

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FASTMAPPROSPECTIVE

Identifier Type: -

Identifier Source: org_study_id

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