Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Objective Masticatory Performance | — | UNRESOLVED | — |
| Oral Health | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Subjective Masticatory Performance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prosthetic oral rehabilitation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Patients who have not received RT in their oncologic treatment (non-irradiated).
- interventionNames
- Procedure: Prosthetic oral rehabilitation
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients who have received RT in their oncologic treatment (irradiated).
- interventionNames
- Procedure: Prosthetic oral rehabilitation
Primary outcomes (4)
- measure
- Objective Masticatory Performance
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available