Head and Neck NeoplasmPEC-PMFNCT04277273
Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris
A study testing Questionnaire in people with Head and Neck Neoplasm and Cleft Palate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm, Cleft Palate, Cleft Lip
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2020to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under guardianship or curatorship
- Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life
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.
Read the 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.
- Conditions
- Head and Neck Neoplasm, Cleft Palate, Cleft Lip
- Being tested
- Questionnaire
- Keywords
- Head and Neck neoplasm, cleft, maxillofacial prosthesis
- Medical subject headings
- Head and Neck Neoplasms, Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires WHOQOL-BREF and GOHAI
| Study group | Role | What they receive |
|---|---|---|
| Patients treated in the MaxilloFacial Prosthesis consultation | Other | Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group) Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the consultation (Day 1)
Secondary outcomes (3)
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)
Measured: During the consultation (Day 1)
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)
Measured: During the consultation (Day 1)
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)
Measured: During the consultation (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start13 Nov 2020
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin POMES, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277273
- Sponsor's protocol ID
- APHP190621
- Other IDs
- 2019-A01640-57
- Acronym
- PEC-PMF
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2019
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Epidemiological Study of Maxillofacial Prosthesis Consultation at Groupe Hospitalier Pitié-Salpêtrière for Sociodemographic, Medical Characteristics and Quality of Life
- ClinicalTrials.gov ID
- NCT04277273
- Acronym / sponsor ID
- PEC-PMF / APHP190621
- Conditions
- Head and Neck Neoplasm, Cleft Palate, Cleft Lip
- Keywords
- Head and Neck neoplasm, cleft, maxillofacial prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated in the MaxilloFacial Prosthesis consultation | Other | Other: QuestionnairePatients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Under guardianship or curatorship
- Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaires WHOQOL-BREF and GOHAI | Other | Patients treated in the MaxilloFacial Prosthesis consultation |
Primary outcome
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.
3 secondary outcomes
Measurement of overall quality of life: Questionnaire WHOQOL-BREF
Time frame: During the consultation (Day 1)
Measurement of quality of life related to oral health: Questionnaire GOHAI
Time frame: During the consultation (Day 1)
Correlation between quality of life and clinical factors
Time frame: During the consultation (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin POMES, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Head and Neck Neoplasm and Cleft Palate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.