RecruitingNot ApplicableNCT07262606

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

Sponsor

Ömer Faruk Okumuş

Enrollment

104 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Periodontal Disease Chronic Periodontitis (Disorder)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria14

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 Criteria6

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).

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Interventions

PROCEDURENon-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.

OTHERSaliva 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.