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

Обзор

Periodontitis is a chronic, irreversible inflammatory disease affecting the supporting structures of the teeth. It is most commonly caused by bacteria in dental plaque, also known as biofilm. The disease typically begins as gingivitis, a reversible inflammation of the gums resulting from plaque accumulation. Without appropriate intervention-such as maintaining proper oral hygiene and removing plaque-gingivitis can progress to periodontitis, leading to the loss of clinical attachment, alveolar bone resorption, and eventually tooth loss. Early diagnosis and regular treatment of periodontal disease are essential to prevent disease progression. The treatment of periodontitis is primarily causal and involves the mechanical removal of plaque. Initial therapy is non-surgical, consisting of scaling and root planing, and may be followed by surgical procedures if required. In addition to mechanical cleaning, increasing attention has been given to adjunctive, non-invasive therapies such as mouth rinses or oral solutions containing chlorhexidine or hydrogen peroxide. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Hydrogen peroxide mouth rinses have been used for more than a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. However, despite their long history of use, clinical studies evaluating hydrogen peroxide-based mouth rinses remain limited and heterogeneous in design, which makes it difficult to compare findings across studies. The objective of this post-marketing clinical study is to generate additional data on the safety and efficacy of a hydrogen peroxide mouth rinse as an adjunctive therapy in the treatment of periodontitis. The study will evaluate two hydrogen peroxide concentrations: 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 12 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 12 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

• Probing depth [Срок оценки: Baseline and Week 12]
• Bleeding on Probing (BOP) [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (4)

• Gingival Index (GI) [Срок оценки: Baseline and Week 12]
• Plaque Index (PI) [Срок оценки: Baseline and Week 12]
• Rate of infection [Срок оценки: Up to week 12]
• Adverse events [Срок оценки: Throughout the 12-week study period]

Критерии участия

Критерии включения

• Systemically healthy participants aged 18 years or older.
• Generalized periodontitis, Stage III, Grade B.
• Presence of three or more periodontal pockets deeper than 5 mm.
• At least 16 natural teeth (excluding wisdom teeth).
• Ability to comply with oral hygiene instructions following the intervention.
• Signed informed consent form after being fully informed about the study.

Критерии исключения

• Periodontal treatment within the past six months.
• Dental procedures (surgery, professional cleaning, scaling and root planing, laser therapy, piezotome) within the past six months.
• Periodontitis, Stage IV.
• Use of mouth rinses or oral gels within the past month.
• Use of antibiotic therapy within the past three months.
• Ongoing therapy with antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medications.
• Systemic diseases such as diabetes, HIV/AIDS, liver diseases, chronic kidney disease, tuberculosis, and autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
• History of cardiovascular diseases, including acute myocardial infarction, angina pectoris, heart failure, atrial fibrillation, atrioventricular block, peripheral artery disease, or stroke.
• Therapy with immunosuppressive agents.
• Allergy to any ingredients of the study products.
• Pregnant or breastfeeding women.

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: NCT07257887 · OROXID-PR-02-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗