Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris

Study Overview
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Brief Summary
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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
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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.

Official Title
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Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life

Conditions
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Head and Neck Neoplasm, Cleft Palate, Cleft Lip

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Patients consulting for Maxillofacial Prosthesis management (Dental Department, Pitié-Salpêtrière Hospital Group) Information and collection of the patient's non-opposition to participation in the research Good written and oral comprehension of the French language Exclusion Criteria: Under guardianship or curatorship Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients treated in the MaxilloFacial Prosthesis consultation<br>Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group) | Other: Questionnaire<br>* Questionnaires WHOQOL-BREF and GOHAI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis | Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected. | During the consultation (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of overall quality of life: Questionnaire WHOQOL-BREF | Questionnaire WHOQOL-BREF (World Health Organization Quality of Life) - 26 items rated on a 5 point likert scale (low score of 1 to high score of 5) | During the consultation (Day 1) | 
| Measurement of quality of life related to oral health: Questionnaire GOHAI | Questionnaire GOHAI (General Oral Health Assessment Index) 12 items rated on a 5 point likert scale (low score of 1 to high score of 5) | During the consultation (Day 1) | 
| Correlation between quality of life and clinical factors | Medical factors will be collected such as : Drug consumption (number of drugs taken per day) Disorders associated with substance loss (number of disorders) Reconstructive surgery (presence or absence) Oral opening limitation (height in millimeters) | During the consultation (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck neoplasm, cleft, maxillofacial prosthesis