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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT04277273
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 14.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasm; Cleft Palate; Cleft Lip	Other: Questionnaire	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life
• Actual Study Start Date: Nov 13, 2020
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients treated in the MaxilloFacial Prosthesis consultation Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group)	Other: Questionnaire; Questionnaires WHOQOL-BREF and GOHAI

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique - Hôpitaux de Paris	Paris		France

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Benjamin POMES, PH, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04277273
• Other Study ID Numbers: APHP190621; 2019-A01640-57
• First Posted: Feb 20, 2020
• Last Update Posted: Jan 28, 2022
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Head and Neck neoplasm; cleft; maxillofacial prosthesis
• Additional relevant MeSH terms: Head and Neck Neoplasms; Cleft Palate; Cleft Lip

Study Results

No Results Posted as of Jan 28, 2022