Saliva Mitofusin-1 levels linked to gum disease severity, smoking, and treatment response

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

This study will test whether the protein Mitofusin-1 in saliva is linked to how bad someone’s periodontitis is and whether their condition improves after standard treatment, including comparisons with smokers and healthy controls.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Erzincan University (Academic / other)
• Locations: 1 site (Erzincan, Erzincan)
• Trial ID: NCT07262606 on ClinicalTrials.gov

What this trial studies

Researchers will collect saliva samples and perform clinical periodontal exams on people with healthy gums, those with mild to severe periodontitis, and smokers with severe periodontitis. Participants with periodontitis will receive standard non-surgical periodontal therapy (scaling and root planing). Salivary Mitofusin-1 (Mfn1) levels will be measured at baseline and again three months after treatment to see how levels change with therapy. The study aims to relate Mfn1 levels to disease severity, smoking status, and treatment response.

Who should consider this trial

Good fit: Ideal candidates are systemically healthy adults with at least 20 natural teeth, no recent antibiotics or periodontal treatment, and who fall into one of the study groups (healthy, mild periodontitis, severe periodontitis, or severe periodontitis with smoking).

Not a fit: People with systemic conditions that affect periodontal status (for example diabetes, immunodeficiency, or malignancy), recent antibiotic or periodontal treatment within six months, or fewer than 20 natural teeth are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, measuring Mfn1 in saliva could offer a simple, noninvasive way to help diagnose disease severity and track treatment response in periodontitis patients.

How similar studies have performed: Using saliva biomarkers for periodontitis has shown promise in prior work, but applying Mitofusin-1 specifically as a salivary biomarker is relatively novel and not yet established.

Eligibility criteria

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).

Where this trial is running

Erzincan, Erzincan

• Erzincan Binali Yıldırım University Faculty of Dentistry — Erzincan, Erzincan, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Ömer F Okumuş, DDS,PhD — Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology
• Study coordinator: Ömer F. Okumuş, DDS,PhD

Conditions Periodontal Disease; Chronic Periodontitis; Mitofusin-1; Saliva; Biomarker; Periodontal Treatment; Smoking