An interventional study of Prosthetic oral rehabilitation in Quality of Life, Objective Masticatory Performance and Subjective Masticatory Performance, sponsored by University of Barcelona. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Barcelona · Not applicable, Interventional, and Screening
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
First session and recruitment:
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:
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:
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.
University of Barcelona is the lead sponsor of 95 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Patients who have not received RT in their oncologic treatment (non-irradiated).
Procedure: Prosthetic oral rehabilitation
Patients who have received RT in their oncologic treatment (irradiated).
Procedure: Prosthetic oral rehabilitation
Prosthetic rehabilitation with fixed and/or removable prosthesis.
Objective Masticatory Performance
The chewing test consists of chewing a latex bag with 2g of silicone during 20 chewing cycles counted by the same subject. It will be repeated 5 times. Until 10 grams of Opto-Zeta silicone have been chewed, the masticatory performance will be calculated by median particle size (MPS).
Time frame: 6 months
Quality of life
It will be analyzed on the basis of the adapted OHIP-14Sp (Oral Health Impact Profile) questionnaire, which will be given to the patients and completed by them. It consists of 14 questions, grouped in pairs and distributed in the following seven categories: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap.
Time frame: 6 months
Subjective masticatory performance
It will be analyzed on the basis of the adapted QMF (Quality of Masticatory Function) questionnaire, which will be given to the patients and completed by them. It consists of 29 questions related to the frequency and ease of chewing different types of food. The questions are classified into five groups: eating and chewing skills, habits, meats, fruits and vegetables.
Time frame: 6 months
Sialometry and salivary pH
▪ Unstimulated salivary secretion: the patient will be seated with the head forward, facilitating the accumulation of saliva on the floor of the mouth. The saliva will be deposited in short intervals in a glass for 5 minutes. The collected content is then measured in a graduated tube. ▪ Stimulated salivary secretion: in the same position as the previous test, the patient will chew a portion of paraffin wax for 5 minutes. Saliva is collected in the glass at short intervals during the chewing period. Afterwards, the content will be measured in a graduated tube. ▪ pH: in one of the vessels with accumulated saliva from the previous tests, the salivary pH will be measured by means of paper strips, whose color will be compared with a visual scale. The color obtained on the strip will be compared with the color scale, which establishes a color for each pH value (1 to 14).
Time frame: 6 months
Plan to share: No
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University of Barcelona