Longitudinal Effects of Head and Neck Radiotherapy on Periodontal and Dental Oral Health: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Clinical Attachment Level (CAL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Change in Clinical Attachment Level (CAL)
时间窗: 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.
次要结局
- Change in Probing Pocket Depth (PPD)(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
- Change in Bleeding on Probing (BOP)(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
- Change in Decayed, Missing, and Filled Teeth (DMFT) Index(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
- Change in Xerostomia Inventory Score(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
- Change in Unstimulated Salivary Flow Rate(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
- Change in Oral Health Impact Profile-14 (OHIP-14) Score(Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy)
研究者
Fatma ElSayed
assistant professor
Ain Shams University