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

Cleft Palate Clinical Trial

— PEC-PMF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277273
• Other study ID #: APHP190621
• Secondary ID: 2019-A01640-57
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate
• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Other:
• Questionnaire
Questionnaires WHOQOL-BREF and GOHAI

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)