NCT05153538

Brief Summary

Implant placement is the solution of choice for replacing missing teeth in a fixed way. However, dental practitioners and surgeons are reluctant to place implants in the population of patients with special needs. They argue different arguments which involve various risk factors. A systematic review shows that it is clear that there is a gap in knowledge about implant placement in patients with special needs in order to argue the choices of prosthetic rehabilitation or abstention based on a scientific evidence-based approach. There is a need of studies with a large number of patients and implants. The Unit of Special Care Dentistry at the University Hospital of Clermont-Ferrand started to place implants in 2007. This study should present the evaluation of the survival, success and failure rate of implants placed under general anesthesia and of the prosthesis rehabilitation that followed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

23 days

First QC Date

November 24, 2021

Last Update Submit

November 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Survival rate

    Informations will be seek to establish the survival rate of each implant treatment according to the Heath Scale for Dental Implants (HSDI) classification of Misch et al.

    2007 - 2021

  • Failure rate

    Informations will be seek to establish whether or not implants are still in the mouth

    2007 - 2021

Eligibility Criteria

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

Patients from the Unit of Special Care Dentistry at the University Hospital of Clermont-Ferrand and followed in the department until the 1st of September 2021 with implants placed by the team under general anesthesia

You may qualify if:

  • patients from the Unit of Special Care Dentistry at the University Hospital of Clermont-Ferrand and followed in the department until the 1st of September 2021
  • implants placed under general anesthesia until the 1st of September 2021

You may not qualify if:

  • patients suffering from dental phobia with no other disability or medical health complex condition
  • implants placed without the need of general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Hospital clermont-Ferrand

Clermont-Ferrand, France

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 10, 2021

Study Start

December 1, 2021

Primary Completion

December 24, 2021

Study Completion

February 15, 2022

Last Updated

December 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations