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Status unknownNCT05153538Updated Dec 10, 2021

Evaluation of Implant Therapies Performed Under General Anesthesia in Patients With Specific Dental Needs

An observational study in Dental Phobia, Disabilities Multiple and Complex Medical Health Condition, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2021-12-10.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Sex
All
01

Study 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.

Read the detailed description

Patients with special needs face multi-level barriers to dental care. Their oral health is worse than those of the general population. Delayed care in one of many reasons that lead to advanced dental disease and a need of more dental treatments. So, patients with special needs are at higher risk of early edentulism, especially since they also are at higher risk of extraction perfomed rather than conservative care. As a result, in addition to social and psychological impacts, this influences largely the oral functioning. Functional problems (mastication, swallowing) appear or are aggravated. A high prevalence of tooth loss exacerbates chewing and swallowing problems. This increases the risk of aspiration and choking, which is a major risk to general health, with bronchopulmonary disease being the leading cause of death in special needs patients. The maintenance of oral functions is therefore essential. However the conventional therapies are not adapted to patients with special needs. In particular, removable prostheses are very poorly tolerated by these patients because of the discomfort and the limitation of autonomy. The maintenance is complicated (higher prevalence of loss and repair). Many authors put forward the difficulty or even the impossibility of making removable prostheses for patients with disorders, Down's syndrome patients, patients with mental retardation or physical limitations and epileptic patients who present a risk of aspiration or ingestion of the prosthesis during seizures. In addition, the presence of associated xerostomia contraindicates the removable prosthesis and indicates the fixed solution. 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 was performed to summarize the literature available about implant survival rates in patients with special needs. Twelve articles could have been included in a meta-analysis. A mean survival rate of 92% at 47,2 months on average, for an average of 23 patients and 81 implants per study was obtained. 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 more 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 presents the evaluation of the survival, success and failure rate of implants placed under general anesthesia and of the prosthesis rehabilitation that followed.

02

Conditions studied

  • Dental Phobia
  • Disabilities Multiple
  • Complex Medical Health Condition
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • patients suffering from dental phobia with no other disability or medical health complex condition
  • implants placed without the need of general anesthesia.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2007 - 2021

  2. Failure rate

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

    Time frame: 2007 - 2021

07

Study locations

1 site
  • CHU Hospital clermont-Ferrand
    Clermont-Ferrand, France
    • Denise FAULKS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05153538
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Dec 10, 2021
Start date
Dec 1, 2021 (estimated)
Primary completion
Dec 24, 2021 (estimated)
Completion
Feb 15, 2022 (estimated)
Last update
Dec 10, 2021

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
04 73 75 11 95

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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