Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery

Обзор

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.

Вмешательства

• Устройство OROXID® forte oral solution
  Patients will use OROXID® forte oral solution two to three times daily for 14 days as an adjunct to standard care.
• Другое Standard of Care (SOC)
  Patients will receive standard of care meaning proper tooth brushing without the use of any mouthwash or other products aimed at reducing bacteria in the oral cavity.

Первичные конечные точки

• Modified Landry Index [Срок оценки: 7 days]

Вторичные конечные точки (5)

• Completely Healed Wounds [Срок оценки: 14 days]
• Mean Early Healing Index [Срок оценки: 7 and 14 days]
• Plaque Index [Срок оценки: 7 and 14 days]
• Pain Relief [Срок оценки: In the first 7 days]
• Infection rate [Срок оценки: 7 and 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• Klinika Križaj — Muljava

Идентификаторы

NCT: NCT06987253 · OROXID-PR-01-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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