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Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris (PEC-PMF)

Primary Purpose

Head and Neck Neoplasm, Cleft Palate, Cleft Lip

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Neoplasm focused on measuring Head and Neck neoplasm, cleft, maxillofacial prosthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hôpitaux de Paris

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients treated in the MaxilloFacial Prosthesis consultation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
December 12, 2019
Last Updated
January 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04277273
Brief Title
Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris
Acronym
PEC-PMF
Official Title
Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm, Cleft Palate, Cleft Lip
Keywords
Head and Neck neoplasm, cleft, maxillofacial prosthesis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated in the MaxilloFacial Prosthesis consultation
Arm Type
Other
Arm Description
Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group)
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Questionnaires WHOQOL-BREF and GOHAI
Primary Outcome Measure Information:
Title
Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis
Description
Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.
Time Frame
During the consultation (Day 1)
Secondary Outcome Measure Information:
Title
Measurement of overall quality of life: Questionnaire WHOQOL-BREF
Description
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)
Time Frame
During the consultation (Day 1)
Title
Measurement of quality of life related to oral health: Questionnaire GOHAI
Description
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)
Time Frame
During the consultation (Day 1)
Title
Correlation between quality of life and clinical factors
Description
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)
Time Frame
During the consultation (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin POMES, PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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