Clinical trial NCT04277273: Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris
Official title: Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasm
Cleft Palate
Cleft Lip
Keywords: Head and Neck neoplasm
cleft
maxillofacial prosthesis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances. Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

Detailed description: Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances (oral-nasal or oral-sinusal communication, removal of the soft palate, removal of part of the lower jaw). These losses are mainly due to the surgical consequences of cancers of the upper aerodigestive tract, trauma or sequelae of labio-palate clefts. Depending on the etiology of substance loss, there are 3 main therapeutics: surgical approach, radiotherapy and chemotherapy. The effects of these treatments are functional, aesthetic and psychological. The functions impacted are chewing, phonation, ventilation and swallowing.

Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics (drug use, type of maxillo-mandibular loss of substance, disorder(s) associated with substance loss, ...).

This study investigates the socio-demographic, medical and quality of life characteristics of Maxillofacial Prosthesis consultation's patients (Department of Dentistry, GHPS) and the potential associations between quality of life and some of these characteristics.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients consulting for Maxillofacial Prosthesis management (Dental Department, Pitié-Salpêtrière Hospital Group)
3. Information and collection of the patient's non-opposition to participation in the research
4. Good written and oral comprehension of the French language

Exclusion Criteria:

1. Under guardianship or curatorship
2. Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment

Primary outcomes:
measure: Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis
timeFrame: During the consultation (Day 1)
Secondary outcomes:
measure: Measurement of overall quality of life: Questionnaire WHOQOL-BREF
timeFrame: During the consultation (Day 1)
measure: Measurement of quality of life related to oral health: Questionnaire GOHAI
timeFrame: During the consultation (Day 1)
measure: Correlation between quality of life and clinical factors
timeFrame: During the consultation (Day 1)
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Benjamin POMES, PH
role: PRINCIPAL_INVESTIGATOR
References: