Ozone Therapy for the Treatment of Oral Mucositis and/or Stomatitis in Patients Undergoing Radio- and Chemotherapy in the Head and Neck District: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Time to Clinical Response of Oral Mucositis (WHO ≤ 1)
研究概览
简要总结
Oral mucositis is a frequent and painful side effect of radio- and chemotherapy, especially in patients with head and neck cancer. It can cause severe discomfort, difficulty eating and swallowing, infections, and interruptions of cancer treatment. This study evaluates the effectiveness of ozone therapy, delivered both professionally in the dental clinic and at home with ozone-based toothpaste, mouthrinse, and gel, in reducing symptoms of oral mucositis and stomatitis.
Fifty-eight adult cancer patients with oral mucositis of at least WHO grade 1 are included. Professional ozone therapy sessions are performed in-office, combined with daily home use of ozonated products. The main goal is to determine how many days are needed for lesions to heal (WHO ≤ 1). A secondary goal is to measure pain reduction using a visual analogue scale (VAS).
This research aims to provide evidence for a supportive care protocol that may improve quality of life, reduce treatment complications, and support cancer patients during therapy.
详细描述
Oral mucositis and stomatitis are common toxicities in patients receiving radiotherapy, chemotherapy, or combined treatment for cancer, particularly in the head and neck region. These lesions significantly impair oral function, nutrition, and quality of life, and can lead to treatment interruptions and increased risk of infection. Current management options are limited and mainly supportive.
Ozone therapy (O₃) has demonstrated antibacterial, antifungal, antiviral, anti-inflammatory, and analgesic properties. In dentistry and oral medicine, it has been applied to promote mucosal healing, modulate inflammatory responses, and enhance local circulation. This study investigates the combined use of professional in-office ozonotherapy and domiciliary application of ozonated toothpaste, mouthrinse, and gel for the treatment of oral mucositis and/or stomatitis in cancer patients.
Fifty-eight patients are enrolled and followed over multiple time points (baseline to day 15). The primary endpoint is the time to clinical response, defined as improvement to WHO grade ≤ 1. Secondary endpoints include reduction in pain intensity assessed by the Visual Analogue Scale (VAS), as well as exploratory comparisons between patients with head and neck cancers and those with malignancies in other anatomical sites.
The trial is designed as a prospective, interventional, single-arm, open-label study. Statistical analyses will include descriptive statistics, repeated measures ANOVA or non-parametric equivalents, with significance set at p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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.
- •Currently undergoing oncologic therapy (radiotherapy, chemotherapy, or combined treatment).
- •Presence of oral mucositis or stomatitis of at least WHO grade 1 at baseline evaluation.
排除标准
- •Pregnant women.
- •Patients with Down syndrome.
- •Patients with epilepsy.
- •Patients with cardiac pacemakers.
- •Patients with marked sensitivity to electrical current.
- •Non-cooperative patients.
研究组 & 干预措施
Ozonotherapy Protocol (Professional and Home-Based)
All participants receive professional in-office ozone therapy with the Ozono DTA device (Sweden-Martina). The first treatment is administered at baseline (T0/T1), followed by additional applications at 48 hours (T2), day 5 (T3), day 8 (T4), day 12 (T5), and day 15 (T6), if clinically indicated. In parallel, participants perform domiciliary treatment for the entire 15-day study period, consisting of daily use of an ozonated toothpaste (DentoO3, 2% ozonated sunflower oil), an ozonated mouthrinse (CollutO3, 4% ozonated sunflower oil solution), and a topical ozonated gel (Ozoral Gel, 15% ozonated sunflower oil), each applied twice daily. Clinical assessments with the WHO oral mucositis scale and the Visual Analogue Scale for pain are performed at all study visits from baseline to day 15.
干预措施: Ozone Therapy (In-Office and Home-Based Treatment) (Other)
结局指标
主要结局
Time to Clinical Response of Oral Mucositis (WHO ≤ 1)
时间窗: Baseline (initial evaluation) (T0); First treatment session (T1); 48 hours (T2; Day 5 (T3); Day 8 (T4); Day 12 (T5); Day 15 (T6).
Clinical response is defined as the first assessment at which oral mucositis improves to WHO grade ≤ 1. Evaluations are performed at baseline (day 0) and during follow-up visits at 48 hours, day 5, day 8, day 12, and day 15. Participants who do not achieve WHO ≤ 1 by day 15 are censored at their last evaluation.
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia