Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris
- Conditions
- Head and Neck NeoplasmCleft PalateCleft Lip
- Interventions
- Other: Questionnaire
- Registration Number
- NCT04277273
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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
- Under guardianship or curatorship
- Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients treated in the MaxilloFacial Prosthesis consultation Questionnaire Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group)
- Primary Outcome Measures
Name Time Method Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis During the consultation (Day 1) Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.
- Secondary Outcome Measures
Name Time Method Measurement of overall quality of life: Questionnaire WHOQOL-BREF During the consultation (Day 1) 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)
Measurement of quality of life related to oral health: Questionnaire GOHAI During the consultation (Day 1) 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)
Correlation between quality of life and clinical factors During the consultation (Day 1) 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)
Trial Locations
- Locations (1)
Assistance Publique - Hôpitaux de Paris
🇫🇷Paris, France