Clinical trial NCT03413475: Oral Quality of Life
Official title: Oral Quality of Life of Patients to be Totally Edentulous at One Arch at Least and Benefiting From the Realization of Immediate and Usual Complete Removable Prostheses.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Odontalgia
Keywords: Edentulism
complete removable prosthesis
quality of life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for prosthetic rehabilitation with the need for a total edentemant of at least one arch, and setting up a complete removable prosthesis

Brief summary: The restorative and surgical odontological department at the Nantes University Hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. This prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions.

The transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. The purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).

Detailed description: Patients are selected at the beginning of their prosthetic rehabilitation and selected patients give their consent for the participation at the clinical trial. The filling of the GOHAI questionnaire is performed in 3 steps:1- before treatment, 2- after teeth extractions and the delivering of immediate complete denture or without immediate prosthetic rehabilitation and 3-during inspection visits after the delivery of the definitive denture.

Eligibility criteria: Inclusion Criteria:

* An adult man or a woman, speaking and understanding French, benefiting from social security cover.
* Patient presenting one or more teeth to be extracted, these extractions resulting in a complete uni or bimaxillary edentulism rehabilitated or not by an immediate complete removable prosthesis.

Exclusion Criteria:

* Patients under the age of majority, patients under protection, protected persons, patients refusing to participate in the study, patients whose follow-up can't be performed, patients who don't speak French and patients who don't benefit from social coverage.
* Patients rehabilitated by immediate partial removable prosthesis (persistence of teeth on the rehabilitated arch).

Primary outcomes:
measure: Geriatric Oral Health Assessment Index (GOHAI) questionnaire
timeFrame: Day - 30
measure: Geriatric Oral Health Assessment Index (GOHAI) questionnaire
timeFrame: Day 0
measure: Geriatric Oral Health Assessment Index (GOHAI) questionnaire
timeFrame: month 1
measure: Geriatric Oral Health Assessment Index (GOHAI) questionnaire
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hospital University of Nantes
Study officials:
affiliation: Nantes University Hospital
name: Laurent Le Guehennec, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: