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

StatusEnrolling by Invitation
PhaseNot applicable
Started
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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.

Record History

  1. Primary completion date: Jun 2024 to Nov 2025
    • Study completion date: Dec 2024 to Dec 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06124222
Lead Sponsor University of Barcelona
Conditions
(from sponsor)		 Quality of Life, Objective Masticatory Performance, Subjective Masticatory Performance, Oral Health
Related terms Head and Neck Neoplasms
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov