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

Обзор

Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy. As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult. One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).

Вмешательства

• Устройство OROXID® forte oral solution
  Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care.
• Устройство OROXID® sensitive oral solution
  Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care.
• Другое Standard of Care
  Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.

Первичные конечные точки

• Gingival Index (GI) at Day 7 [Срок оценки: Baseline and Day 7]
• Plaque Index (PI) at Day 7 [Срок оценки: Baseline and Day 7]
• Bleeding on Probing (BOP) at Day 7 [Срок оценки: Baseline and Day 7]

Вторичные конечные точки (5)

• Gingival Index (GI) at Day 14 and 28 [Срок оценки: Baseline, Day 14, and Day 28]
• Plaque Index (PI) at Day 14 and 28 [Срок оценки: Baseline, Day 14, and Day 28]
• Bleeding on Probing (BOP) at Day 14 and 28 [Срок оценки: Baseline, Day 14, and Day 28]
• Rate of infection [Срок оценки: Baseline to Day 28]
• Adverse events [Срок оценки: Baseline to Day 28]

Критерии участия

Критерии включения

• Systemically healthy participants aged 18 years or older.
• Presence of at least 20 natural teeth.
• Probing pocket depth less than or equal to 3 mm.
• Presence of bleeding on probing in more than 10% of sites.
• Mean Gingival Index (Silness \& Löe) of at least 1.
• Ability and willingness to follow oral hygiene instructions after the intervention.
• Signed informed consent form after being informed about the study.

Критерии исключения

• Periodontal treatment within the last three months.
• Diagnosis of periodontitis.
• Use of mouth rinses or oral gels within the last month.
• Use of antibiotic therapy within the last three months.
• Known allergy or hypersensitivity to any components of the investigational products.
• Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
• Presence of systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic kidney disease, tuberculosis, or autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
• Use of immunosuppressive medications.
• Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
• Pregnant or breastfeeding women.
• Smokers.

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 · 2 центра

• Klinika Križaj Ljubljana — Ljubljana
• Ustna medicina d.o.o. — Ljubljana

Идентификаторы

NCT: NCT07270705 · OROXID-PR-03-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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