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Completed

NCT Number: NCT04277273

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaires WHOQOL-BREF and GOHAI

Primary outcomes

  1. Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis

    Time frame: During the consultation (Day 1)

    Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.

Secondary outcomes

  1. Measurement of overall quality of life: Questionnaire WHOQOL-BREF

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PEC-PMF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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