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

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Oral Health; Objective Masticatory Performance; Subjective Masticatory Performance
• Intervention / Treatment: Procedure: Prosthetic oral rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08901
      • Carlos Moreno Soriano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients who have not received RT in their oncologic treatment (non-irradiated).	Procedure: Prosthetic oral rehabilitation; Prosthetic rehabilitation with fixed and/or removable prosthesis.
Experimental: Group B; Patients who have received RT in their oncologic treatment (irradiated).	Procedure: Prosthetic oral rehabilitation; Prosthetic rehabilitation with fixed and/or removable prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	6 months

Collaborators and Investigators

• Sponsor: University of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Head Neck Cancer; Masticatory Performance; Oral Rehabilitation
• Other Study ID Numbers: 17/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No