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

NCT06124222 | Enrolling By Invitation DMC

• 1 other identifier: 17/2021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

• 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)
• Oral health status.
• Sialometry and salivary pH.
• Subjective masticatory performance.
• Objective masticatory performance.
• Quality of life.
• \- Third session (follow-up 6 months)
• 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

Keywords

Masticatory Performance; Quality of Life; Head Neck Cancer; Oral Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients who have not received RT in their oncologic treatment (non-irradiated).

Procedure: Prosthetic oral rehabilitation

Group B

EXPERIMENTAL

Patients who have received RT in their oncologic treatment (irradiated).

Procedure: Prosthetic oral rehabilitation

Interventions

Prosthetic oral rehabilitation PROCEDURE

Prosthetic rehabilitation with fixed and/or removable prosthesis.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects under 18 years of age and/or who do not accept the conditions of the study.
• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Carlos Moreno Soriano

L'Hospitalet de Llobregat, Barcelona, 08901, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: There will be double-blind blinding, since neither the participant nor the principal investigator will be aware of which group (A/B) each patient belongs to.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: * 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).

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: November 17, 2021
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)