Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277273
Acronym
PEC-PMF
Enrollment
83
Registered
2020-02-20
Start date
2020-11-13
Completion date
2021-05-07
Last updated
2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip, Cleft Palate, Head and Neck Neoplasm

Keywords

Head and Neck neoplasm, cleft, maxillofacial prosthesis

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.

Interventions

OTHERQuestionnaire

Questionnaires WHOQOL-BREF and GOHAI

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial ProsthesisDuring the consultation (Day 1)Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.

Secondary

MeasureTime frameDescription
Measurement of overall quality of life: Questionnaire WHOQOL-BREFDuring 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 GOHAIDuring 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 factorsDuring 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026