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

NCT ID: NCT04277273

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2021-05-07

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.

Conditions

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Head and Neck Neoplasm Cleft Palate Cleft Lip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients treated in the MaxilloFacial Prosthesis consultation

Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group)

Group Type OTHER

Questionnaire

Intervention Type OTHER

Questionnaires WHOQOL-BREF and GOHAI

Interventions

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Questionnaire

Questionnaires WHOQOL-BREF and GOHAI

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin POMES, PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2019-A01640-57

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190621

Identifier Type: -

Identifier Source: org_study_id

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