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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and Neck Radiotherapy Cohort | Adult patients with head and neck cancer undergoing standard external beam radiotherapy who are followed longitudinally to evaluate periodontal health, dental outcomes, salivary function, and oral health-related quality of life. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | 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. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | 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. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Change in Bleeding on Probing (BOP) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with head and neck cancer receiving external beam radiotherapy at a tertiary referral hospital who are followed longitudinally for oral and periodontal health outcomes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Maher Teaching Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D010510 | Periodontal Diseases |
| D014987 | Xerostomia |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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Percentage of periodontal sites exhibiting bleeding on probing as a measure of periodontal inflammation. |
| Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Change in Decayed, Missing, and Filled Teeth (DMFT) Index | Dental caries experience assessed using the Decayed, Missing, and Filled Teeth (DMFT) index to evaluate cumulative dental disease burden. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Change in Xerostomia Inventory Score | Patient-reported xerostomia severity measured using the validated Xerostomia Inventory questionnaire. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Change in Unstimulated Salivary Flow Rate | Unstimulated whole salivary flow rate measured in milliliters per minute using the passive drooling collection method. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| Change in Oral Health Impact Profile-14 (OHIP-14) Score | Oral health-related quality of life assessed using the OHIP-14 questionnaire. | Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |