Clinical Trial

Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC

Enrolling by Invitation
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Record status
This record was last updated December 5, 2024 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-03.
Trial Details
NCT Number NCT06124222
Lead Sponsor University of Barcelona
Conditions Quality of Life, Objective Masticatory Performance, Subjective Masticatory Performance, Oral Health
Enrollment 21 participants
Start Date 2021-11-17
Primary Completion 2025-11 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-05