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Dental PhobiaNCT05153538

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

An observational study of Dental Phobia and Disabilities Multiple, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
57 participants
Where
1 siteFrance
Study dates
1 Dec 2021to 15 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Hospital clermont-Ferrand

    Clermont-Ferrand

    Denise FAULKS

Other trials in France

About this study

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2007 - 2021

  2. Failure rate

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

    Measured: 2007 - 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion24 Dec 2021 (estimated)
  4. Study completion15 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153538
Sponsor's protocol ID
2021 FAULKS Th-imp
Status last verified
Nov 2021
First submitted
24 Nov 2021
Last updated
10 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Phobia and Disabilities Multiple, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: 2007 - 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.

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