NCT06745232

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

December 17, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

fixed prosthesisstereophotogrammetryimmediate loading

Outcome Measures

Primary Outcomes (1)

  • Prosthetic Success

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

    3 months

Study Arms (1)

FAST MAP

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

Device: FAST MAP

Interventions

FAST MAPDEVICE

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

FAST MAP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PTV

Roma, RM, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doc Researcher

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

January 10, 2025

Primary Completion

May 25, 2025

Study Completion

August 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations