Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response

Обзор

Periodontitis (gum inflammation) is a common disease worldwide. This study aims to investigate a novel biomarker, a protein called Mitofusin-1 (Mfn1), in saliva that may be associated with the severity of periodontitis and response to treatment. The study will include periodontally healthy individuals, individuals with mild to severe periodontitis, and smokers with severe periodontitis. Participants will receive saliva samples and undergo clinical periodontal examinations. Individuals with periodontitis will receive standard periodontal treatment, and changes in Mfn1 levels will be assessed 3 months after treatment. The study is expected to shed light on the potential utility of Mfn1 as a marker in the diagnosis and follow-up of periodontitis.

Вмешательства

• Процедура Non-surgical Periodontal Therapy (Scaling and Root Planing)
  A standard periodontal treatment procedure that involves the removal of dental plaque and calculus (tartar) from the tooth surfaces and root pockets. This is followed by root planing to smooth the root surfaces, allowing the gingiva to heal and reattach to the tooth.
• Другое Saliva Collection
  Collection of unstimulated whole saliva. Participants will be asked to allow saliva to pool in the floor of the mouth and then passively drool into a sterile collection tube. A total of 1.5 ml of saliva will be collected from each participant.

Первичные конечные точки

• Salivary Mitofusin-1 (Mfn1) Concentration at Baseline [Срок оценки: Baseline]

Вторичные конечные точки (7)

• Change in Salivary Mfn1 Concentration After Periodontal Therapy [Срок оценки: Baseline and 3 months]
• Salivary Glutathione Peroxidase (GPx) Concentration [Срок оценки: Baseline]
• Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration [Срок оценки: Baseline]
• Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD) [Срок оценки: Baseline]
• Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL) [Срок оценки: Baseline]
• Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI) [Срок оценки: Baseline]
• Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Willing and able to provide written informed consent.
• Systemically healthy (no history of diabetes mellitus, immunodeficiency, malignancy, or other systemic conditions that could affect periodontal status).
• Have a minimum of 20 natural teeth (excluding third molars).
• No antibiotic therapy or periodontal treatment in the last 6 months.

For Healthy Control Group:

No clinical attachment loss. Probing depth ≤ 3 mm. No radiographic evidence of bone loss. Low gingival and plaque index scores.

For Mild Periodontitis Group:

Diagnosed with Stage I or II periodontitis according to the 2018 AAP/EFP classification.

Clinical attachment loss of 1-4 mm. Radiographic bone loss of ≤15-33%. Non-smoker.

For Severe Periodontitis Group:

Diagnosed with Stage III or IV periodontitis according to the 2018 AAP/EFP classification.

Clinical attachment loss ≥ 5 mm. Radiographic bone loss to the mid-advanced level of the root. Non-smoker.

For Severe Periodontitis with Smoking Group:

Meets all criteria for the Severe Periodontitis Group. Regular smoker (at least 10 cigarettes per day for a minimum of 5 years).

Критерии исключения

• Fewer than 20 natural teeth (excluding third molars).
• Presence of any systemic disease (e.g., diabetes mellitus, immunological disorders, cancer).
• Use of antibiotics or receiving periodontal treatment in the last 6 months.
• Pregnancy or lactation.
• For non-periodontitis groups (Healthy Control): Any signs of periodontitis.
• For periodontitis groups (all): History of smoking cessation for at least 5 years (must be either a current regular smoker or a never-smoker, depending on the group definition).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Turkey (Türkiye) · 1 центр

• Erzincan Binali Yıldırım University Faculty of Dentistry — Erzincan

Идентификаторы

NCT: NCT07262606 · EBYU-OKUMUS-MFN1-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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