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

Ömer Faruk Okumuş

Status: Enrolling

Conditions: Chronic Periodontitis (Disorder); Periodontal Disease

Treatments: Other: Saliva Collection; Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing)

Study type: Interventional

Funder types: Other

Identifiers

NCT07262606

EBYU-OKUMUS-MFN1-2025

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 4 patient groups

Healthy Control Group

Sham Comparator group

Description:

Periodontally healthy individuals with no clinical attachment loss, probing depth ≤3 mm, no radiographic bone loss, and low gingival and plaque index scores.

Treatment:

Other: Saliva Collection

Mild Periodontitis Group

Experimental group

Description:

Non-smoking individuals diagnosed with Stage I-II periodontitis according to the AAP/EFP 2018 classification, with clinical attachment loss of 1-4 mm and ≤15-33% radiographic bone loss.

Treatment:

Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing)

Other: Saliva Collection

Severe Periodontitis Group

Experimental group

Description:

Non-smoking individuals diagnosed with Stage III-IV periodontitis according to the AAP/EFP 2018 classification, with clinical attachment loss ≥5 mm and radiographic bone loss to the mid-advanced level of the root.

Treatment:

Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing)

Other: Saliva Collection

Severe Periodontitis with Smoking Group

Experimental group

Description:

Individuals who meet the criteria for the Severe Periodontitis Group and are also regular smokers (at least 10 cigarettes per day for a minimum of 5 years).

Treatment:

Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing)

Other: Saliva Collection