New Stereophotogrammetry System to Capture Complete-arch Impression

March 4, 2025 updated by: Paolo Carosi, University of Rome Tor Vergata

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients in need of complete arch rehabilitations with dental implants and fixed dental prosthesis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FAST MAP
Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression
Device: FAST MAP
Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic Success
Time Frame: 3 months
Prosthetic success of interim prosthesis in term of passivity and tissues adaptability
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

May 25, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTMAPPROSPECTIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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