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Recruiting NCT06745232

New Stereophotogrammetry System to Capture Complete-arch Impression

Observational Prosthetic Complication Prosthesis Failure, Dental

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FAST MAP.
Who it may be relevant to
Registry conditions: Prosthetic Complication, Prosthesis Failure, Dental. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Use of a New Stereophotogrammetry System to Capture Intra-operative Complete-arch Impression

Overview

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

Interventions

  • Device FAST MAP
    Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression

Primary outcome measures

  • Prosthetic Success [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • PTV — Roma

Identifiers

NCT: NCT06745232 · FASTMAPPROSPECTIVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗