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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 89.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Madhura Sharma
Advanced Centre For Treatment Research, Education and Treatment in In Cancer Tata Memorial Centre