MedTrace Logo

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

NCT06124222 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Quality of Life
  • Objective Masticatory Performance
  • Subjective Masticatory Performance
  • Oral Health

Interventions

PROCEDURE

Prosthetic oral rehabilitation

Prosthetic rehabilitation with fixed and/or removable prosthesis.

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124222 on ClinicalTrials.gov