Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma, Periodontal Disease, Xerostomia
Conditions
Keywords
Head and neck radiotherapy, periodontal health, radiation-induced oral complications, dental caries, salivary dysfunction, oral health quality of life
Brief summary
This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.
Detailed description
This prospective longitudinal cohort study investigates the effects of head and neck radiotherapy on periodontal health, dental outcomes, salivary gland function, and oral health-related quality of life. Adult patients with histologically confirmed head and neck malignancies scheduled to receive external beam radiotherapy are enrolled and followed longitudinally. Clinical assessments are conducted at baseline prior to radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months post-treatment. Periodontal evaluation includes clinical attachment level, probing pocket depth, plaque index, gingival index, and bleeding on probing, recorded at six sites per tooth using standardized periodontal examination protocols. Dental outcomes include decayed, missing, and filled teeth index, radiation-associated caries incidence, and tooth mobility. Salivary gland function is assessed using unstimulated whole saliva collection. Patient-reported outcomes include xerostomia severity and oral health-related quality of life using validated questionnaires. Radiotherapy characteristics including technique, total dose, fractionation schedule, mandibular field involvement, and concurrent chemotherapy are recorded. Longitudinal changes in oral health outcomes are analyzed to identify patterns of disease progression and potential predictors of radiotherapy-related oral complications. This study aims to generate clinical evidence to improve preventive strategies, early detection, and supportive oral care protocols for patients receiving head and neck radiotherapy.
Interventions
None listed
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Histologically confirmed head and neck malignancy * Planned radiotherapy dose ≥50 Gy * Presence of at least 20 natural teeth * No periodontal treatment during the preceding 6 months * Ability to comply with the scheduled follow-up visits
Exclusion criteria
* Previous head and neck radiotherapy * Autoimmune salivary gland disorders * Current bisphosphonate or anti-resorptive therapy * Pregnancy * Uncontrolled systemic disease (HbA1c \>9% for diabetic patients) * Severe periodontal destruction requiring immediate surgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Mean change in clinical attachment level measured in millimeters using a standardized UNC-15 periodontal probe at six sites per tooth. CAL is used as the primary indicator of periodontal tissue loss following radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Mean probing pocket depth measured in millimeters at six sites per tooth using a standardized UNC-15 periodontal probe as an indicator of periodontal pocket severity. |
| Change in Bleeding on Probing (BOP) | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Percentage of periodontal sites exhibiting bleeding on probing as a measure of periodontal inflammation. |
| Change in Decayed, Missing, and Filled Teeth (DMFT) Index | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Dental caries experience assessed using the Decayed, Missing, and Filled Teeth (DMFT) index to evaluate cumulative dental disease burden. |
| Change in Xerostomia Inventory Score | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Patient-reported xerostomia severity measured using the validated Xerostomia Inventory questionnaire. |
| Change in Unstimulated Salivary Flow Rate | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Unstimulated whole salivary flow rate measured in milliliters per minute using the passive drooling collection method. |
| Change in Oral Health Impact Profile-14 (OHIP-14) Score | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy | Oral health-related quality of life assessed using the OHIP-14 questionnaire. |
Countries
Egypt
Outcome results
None listed