Quality of LifeNCT06124222
Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC
A study testing Prosthetic oral rehabilitation in people with Quality of Life and Objective Masticatory Performance, run by University of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Objective Masticatory Performance, Subjective Masticatory Performance
- What is being tested?
- Prosthetic oral rehabilitation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prosthetic Rehabilitation and Its Influence on Masticatory Performance and Quality of Life in Patients Treated for Head and Neck Cancer
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.
Read more
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:
- Oral health status.
- Sialometry and salivary pH.
- Subjective masticatory performance.
- Objective masticatory performance.
- Quality of life.
- - Prosthodontic treatment.
- - 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.
- - 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.
Read the 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.
- Conditions
- Quality of Life, Objective Masticatory Performance, Subjective Masticatory Performance, Oral Health
- Being tested
- Prosthetic oral rehabilitation
- Keywords
- Masticatory Performance, Quality of Life, Head Neck Cancer, Oral Rehabilitation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic oral rehabilitationProcedure or surgery
Prosthetic rehabilitation with fixed and/or removable prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients who have not received RT in their oncologic treatment (non-irradiated). Receives: Procedure: Prosthetic oral rehabilitation |
| Group B | Experimental | Patients who have received RT in their oncologic treatment (irradiated). Receives: Procedure: Prosthetic oral rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start17 Nov 2021
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Moreno Soriano, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124222
- Sponsor's protocol ID
- 17/2021
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Rehabilitation and Its Influence on Masticatory Performance and Quality of Life in Patients Treated for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06124222
- Acronym / sponsor ID
- 17/2021
- Conditions
- Quality of Life, Objective Masticatory Performance, Subjective Masticatory Performance, Oral Health
- Keywords
- Masticatory Performance, Quality of Life, Head Neck Cancer, Oral Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Oral health status.
- Sialometry and salivary pH.
- Subjective masticatory performance.
- Objective masticatory performance.
- Quality of life.
- - Prosthodontic treatment.
- - 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.
- - 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Prosthetic oral rehabilitationPatients who have not received RT in their oncologic treatment (non-irradiated). |
| Group B | Experimental | Procedure: Prosthetic oral rehabilitationPatients who have received RT in their oncologic treatment (irradiated). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic oral rehabilitationProsthetic rehabilitation with fixed and/or removable prosthesis. | Procedure or surgery | Group A, Group B |
Primary outcome
Objective Masticatory Performance
Time frame: 6 months
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).
Quality of life
Time frame: 6 months
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.
Subjective masticatory performance
Time frame: 6 months
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.
Sialometry and salivary pH
Time frame: 6 months
▪ 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic oral rehabilitation in people with Quality of Life and Objective Masticatory Performance, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Masticatory Performance (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.