Clinical trial NCT06124222: Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC
Official title: Prosthetic Rehabilitation and Its Influence on Masticatory Performance and Quality of Life in Patients Treated for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Quality of Life
Objective Masticatory Performance
Subjective Masticatory Performance
Oral Health
Keywords: Masticatory Performance
Quality of Life
Head Neck Cancer
Oral Rehabilitation
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group A: patients who have not received radiotherapy (RT) in their oncologic treatment (non-irradiated).
* Group B: patients who have received radiotherapy (RT) in their oncologic treatment (irradiated).
Primary purpose: SCREENING

Brief 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.

Detailed description: The adverse effects of oncological treatment can alter both the functional and esthetic capabilities of patients, resulting in a diminished quality of life. Dental rehabilitation with prostheses is used to restore the loss of these parameters. Therefore, it is important to know whether patients treated for head and neck cancer improve their masticatory performance, and therefore their quality of life, when rehabilitated with fixed or removable prostheses.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subjects under 18 years of age and/or who do not accept the conditions of the study.
* Diagnosis of cancer in regions other than those mentioned in the inclusion criteria.
* 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.

Primary outcomes:
measure: Objective Masticatory Performance
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Subjective masticatory performance
timeFrame: 6 months
measure: Sialometry and salivary pH
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Carlos Moreno Soriano
state: Barcelona
Study officials:
References: