Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC
NCT ID: NCT06124222
Last Updated: 2024-12-05
Study Results
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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ENROLLING_BY_INVITATION
NA
21 participants
INTERVENTIONAL
2021-11-17
2025-12-31
Brief Summary
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Hypothesis Prosthetic rehabilitation with fixed and/or removable prostheses modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in non-irradiated patients treated for head and neck cancer compared to irradiated patients.
Study population The study population will consist of patients treated for head and neck cancer who are candidates for prosthetic rehabilitation. The type of prosthetic treatment recommended will be determined by a dental expert in the treatment of these patients.
Interventions
1. \- First session and recruitment:
* Oral health status.
* Sialometry and salivary pH.
* Subjective masticatory performance.
* Objective masticatory performance.
* Quality of life.
2. \- Prosthodontic treatment.
3. \- Second session (after insertion of the prosthesis)
After an adaptation period of ± 15-30 days from the insertion of the prosthesis, the recordings carried out in the first session will be performed again:
* Oral health status.
* Sialometry and salivary pH.
* Subjective masticatory performance.
* Objective masticatory performance.
* Quality of life.
4. \- Third session (follow-up 6 months)
After a period of time of 3 months ± 7 days after the second session, the recordings carried out in the first and second sessions will be performed again:
* Oral health status.
* Sialometry and salivary pH.
* Subjective masticatory performance.
* Objective masticatory performance.
* Quality of life.
Detailed Description
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Masticatory function is altered after oncologic treatment in patients with head and neck cancer, causing a decrease in their quality of life. Therefore, there is a need to know whether patients treated for head and neck cancer improve their masticatory performance and masticatory function, and therefore their quality of life, when rehabilitated with fixed or removable prostheses, as well as to know whether this variation in parameters is maintained over time. In addition, it is important to evaluate other aspects that are also directly related to quality of life and masticatory function, such as oral health, the level of salivary secretion and its pH.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* Group B: patients who have received radiotherapy (RT) in their oncologic treatment (irradiated).
SCREENING
DOUBLE
Study Groups
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Group A
Patients who have not received RT in their oncologic treatment (non-irradiated).
Prosthetic oral rehabilitation
Prosthetic rehabilitation with fixed and/or removable prosthesis.
Group B
Patients who have received RT in their oncologic treatment (irradiated).
Prosthetic oral rehabilitation
Prosthetic rehabilitation with fixed and/or removable prosthesis.
Interventions
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Prosthetic oral rehabilitation
Prosthetic rehabilitation with fixed and/or removable prosthesis.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed and treated for head and neck cancer in the stable phase of their oncologic pathology.
* Patients in need of prosthetic rehabilitation treatment and who agree to be treated.
* Present a tumor recurrence at the time of the study, undefined oncologic evolutionary situation or under oncologic treatment.
* Presence of orofacial pain or craniomandibular dysfunction hindering mandibular movement and or participation in the study.
* Present a disability to complete the different records.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Barcelona
OTHER
Responsible Party
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Carlos Moreno Soriano
MSc
Locations
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Carlos Moreno Soriano
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Other Identifiers
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17/2021
Identifier Type: -
Identifier Source: org_study_id