NCT06124222Enrolling by invitation
Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC
Prosthetic Rehabilitation and Its Influence on Masticatory Performance and Quality of Life in Patients Treated for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main goal of this clinical trial (pilot study) is to evaluate whether prosthetic rehabilitation modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in patients treated for head and neck cancer before and after the placement of fixed and/or removable prostheses. 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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 3 Nov 2023
- Start date
- 17 Nov 2021
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- University of Barcelona
- Diseases
- Head and neck cancer
- NCT number
- NCT06124222
What you commit to
- Study type: Interventional
- Planned participants: 21
- From 17 Nov 2021 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of cancer in regions other than those mentioned in the inclusion criteria.
Age
- Subjects under 18 years of age and/or who do not accept the conditions of the study.
Other
- 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.
Who the study is looking for
- Subjects over 18 years of age who accept the conditions of the study.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carlos Moreno Soriano Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.