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OpenTrials
Recruiting

NCT Number: NCT06745232

New Stereophotogrammetry System to Capture 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

Recruiting

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Key information

Conditions

Prosthetic Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Failure, Dental

Sex eligibility

All sexes

Study type

Observational

Primary location

PTV

Roma, RM, 00133, Italy

Location status: Recruiting

Location contact

Paolo Carosi, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAST MAP

Device

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

Primary outcomes

  1. Prosthetic Success

    Time frame: 3 months

    Prosthetic success of interim prosthesis in term of passivity and tissues adaptability

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Carosi, PhD

CONTACT

[email protected]

327798699 ext. +39

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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