Tinder Fungus as an Adjunct to Non-surgical Periodontal Therapy for Periodontitis

Официальное название

Tinder Fungus (Fomes Fomentarius) as an Adjunct to Non-surgical Periodontal Therapy for Periodontitis: A Randomized Controlled Trial

Обзор

The goal of this interventional clinical study is to learn if a Tinder fungus-based formulation -specifically a toothpaste and oral supplement powder-works as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis. The main questions it aims to answer is: • Does the Tinder fungus-based formulation as an adjunct to NSPT reduce bleeding on probing more than a commercially available toothpaste as an adjunct to NSPT? Researchers will compare tinder fungus toothpaste and oral powder as an adjunct to NSPT to a commercially available toothpaste as an adjunct to NSPT to see if the Tinder fungus-based formulation works as adjuncts to NSPT in patients with periodontitis. Participants will: * Take tinder fungus toothpaste and oral powder or a commercially available toothpaste as an adjunct to NSPT twice daily for 30 consecutive days * Visit the clinic at least twice including a visit before and after the intervention * Keep a diary documenting their well-being and the number of times they used the toothpastes in the morning and evening.

Вмешательства

• Другое Tinder fungus-based formulation
  Participants will receive Tinder fungus (Fomes fomentarius)-based formulations including a toothpaste plus an oral supplement powder as adjuncts to non-surgical periodontal therapy (NSPT).
• Другое Commercially available toothpaste
  A standard commercially available toothpaste administered as an adjunct to NSPT.

Первичные конечные точки

• Bleeding on probing (BoP in %) change [Срок оценки: changes from baseline (T0; 1 day before intervention starts) to reevaluation (T1; 5 weeks (±1 week) after intervention start)]

Критерии участия

Критерии включения

• Patients diagnosed with Stage III or IV periodontitis
• Patients who have not yet initiated periodontal therapy
• Patients who have at least 20 remaining teeth
• Patients who are willing to use an electric toothbrush
• Patients who are willing to use interdental brushes

Критерии исключения

• Patients who have previously received treatment for periodontitis
• Patients who have already undergone or initiated periodontal therapy
• Patients with a known allergy or intolerance to any component of the toothpaste or the powder
• Patients who are already using a product that contains tinder fungus (Fomes fomentarius)
• Patients who, at the time of periodontal treatment, are undergoing active systemic cancer therapy (e.g., chemotherapy or immunotherapy) or radiotherapy in the head and neck region, or for whom such therapy is planned. Previous illnesses or completed therapies do not constitute an exclusion criterion, provided that no current or planned treatment exists that could influence the periodontal treatment outcome or pose an increased risk for the participants.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Австрия · 1 центр

• Dental Clinic of the Sigmund Freud Private University — Vienna

Идентификаторы

NCT: NCT07482878 · 19113705

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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