Occurrence of Osteoradionecrosis and Healing Outcomes Following Dental Extractions in Head and Neck Cancer Patients Post-Radiotherapy in a Tertiary Health Care Centre: An Ambispective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- The outcome measures would be recorded depending on the evaluation of healing (soft tissue and bone healing) after dental extractions in patients who have undergone RT the for HNC.
研究概览
简要总结
Head and neck cancer includes different types, each with its own causes, symptoms, and treatments. According to Globocan 2022, more than 805,000 new cases are reported worldwide every year, leading to over 417,000 deaths. In India, this type of cancer is especially common and requires intense treatment with a long recovery period.
Radiation therapy (RT) is a key treatment for head and neck cancer, but it can have side effects like mouth sores, dry mouth, trouble swallowing, and even damage to the jawbone (a condition called osteoradionecrosis or ORN). ORN happens when radiation harms the small blood vessels in the jaw, cutting off the bone’s supply of oxygen and nutrients. This makes the bone weak and unable to heal properly, sometimes leading to pain, infections, and even exposed bone that doesn’t heal. ORN can develop months or even years after treatment.
To reduce the risk, doctors often suggest removing unhealthy teeth before radiation and keeping a close watch on dental health afterward. Usually, problematic teeth are taken out at least 14 days before treatment. However, there is some debate about whether teeth that can’t be saved should also be removed after radiation. This study aims to understand how well patients heal after dental extractions following RT and to determine the safest timing for these procedures.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 89.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC).
- •Patients who have received RT with curative intent (definitive or adjuvant), with or without concomitant chemotherapy; Patients requiring or undergone extraction of one or more non-restorable teeth post-RT.
- •Patients with no evidence of disease or metastasis following RT.
- •All adults, irrespective of race & ethnicity are eligible for this trial.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Active or recurrent HNC requiring ongoing treatment.Patients who have received palliative-intent head and neck RT, Uncontrolled systemic diseases, such as poorly managed diabetes or cardiovascular conditions, that may impair wound healing.
- •Inability to attend follow-up visits or comply with post-extraction care recommendations.
结局指标
主要结局
The outcome measures would be recorded depending on the evaluation of healing (soft tissue and bone healing) after dental extractions in patients who have undergone RT the for HNC.
时间窗: Evaluation of healing would be conducted at 3 months (baseline), 6 months and 12 months—aligned with the patient’s scheduled oncology follow-up visits—to assess healing at the extraction site and identify any potential complications.
次要结局
未报告次要终点
研究者
Dr Madhura Sharma
Advanced Centre For Treatment Research, Education and Treatment in In Cancer Tata Memorial Centre