Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Modified Landry Index
研究概览
简要总结
Oral tissue healing is significantly affected by the high bacterial load and constant mechanical stress within the oral cavity. To control bacterial colonization and support healing, both topical and systemic treatments-such as antibiotics and anti-inflammatory agents-are commonly recommended. In addition to pharmacological therapies, mouthwashes containing peroxide, hyaluronic acid, chitosan, or chlorhexidine are often used to maintain low levels of pathogenic bacteria.
However, current recommendations for mouthwash use are primarily based on their antibacterial properties in a healthy oral environment. Evidence supporting their role in promoting wound healing, particularly after oral surgery, remains limited.
OROXID® mouthwash is a medical device formulated with active oxygen (peroxide compounds). It supports the prevention and relief of inflammation in gingival and paranasal tissues through mechanical action: the release of oxygen bubbles helps cleanse tissues by removing debris. OROXID® acts locally on the mucosal microenvironment by moistening, oxygenating, and clearing away particles and dead cells. Additionally, its slightly acidic pH (between 3 and 5) helps inhibit microbial growth.
The investigators hypothesize that OROXID® may reduce post-operative side effects and complications following wisdom tooth extraction and contribute to faster wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Systemically healthy individuals aged 18 years or older.
- •Indicated for surgical removal of an erupted or unerupted tooth and/or apicoectomy.
- •Ability and willingness to comply with post-operative oral hygiene instructions.
- •Signed informed consent form prior to participation in the study.
排除标准
- •Receipt of periodontal treatment within the past 3 months.
- •Use of mouthwashes or oral gels in the past month.
- •Presence of active gingivitis around the tooth scheduled for extraction.
- •Known allergy to any ingredients of the investigational products.
- •Presence of inflammatory conditions in the oral cavity, such as lichen planus, bullous lesions, or active gingivitis.
- •Immunocompromised individuals.
- •Known allergy to penicillin or diclofenac.
- •Pregnant or breastfeeding women.
- •Smokers who consume more than 15 cigarettes per day.
结局指标
主要结局
Modified Landry Index
时间窗: 7 days
Differences in the total score of the individual components of the Modified Landry Index between the active and control groups. This entails evaluating the following parameters in a comparative manner using a dichotomic score: gingival color (0 = red, 1 = pink); granulation tissue (0 = present, 1 = absent); tissue epithelialization (0 = partial/1 = complete); swelling (0 = pres- ence, 1 = absent); bleeding on palpation (0 = present, 1 = absent); sup- puration on palpation (0 = present, 1 = absent). The total score, ranging from 0 to 6, reflects the overall quality of healing, with higher scores indicating more favorable outcomes.
次要结局
- Infection rate(7 and 14 days)
- Completely Healed Wounds(14 days)
- Mean Early Healing Index(7 and 14 days)
- Plaque Index(7 and 14 days)
- Pain Relief(In the first 7 days)
