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NCT Number: NCT07262606

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yıldırım University Faculty of Dentistry

Erzincan, 24002, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ömer Faruk Okumuş

CONTACT

[email protected]

05532140969

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non-surgical periodontal therapy (Scaling and root planing)

Procedure

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.

Saliva Collection

Other

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.

Primary outcomes

  1. Salivary Mitofusin-1 (Mfn1) Concentration at Baseline

    Time frame: Baseline

    Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group.

Secondary outcomes

  1. Change in Salivary Mfn1 Concentration After Periodontal Therapy

    Time frame: Baseline and 3 months

    Difference in salivary Mfn1 concentration (ng/mL) measured using ELISA at baseline and 3 months after non-surgical periodontal therapy in the periodontitis groups.

  2. Salivary Glutathione Peroxidase (GPx) Concentration

    Time frame: Baseline

    GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L).

  3. Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration

    Time frame: Baseline

    8-OHdG concentration measured in saliva using ELISA (ng/mL).

  4. Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)

    Time frame: Baseline

    Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and probing depth measured with a manual periodontal probe (mm).

  5. Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL)

    Time frame: Baseline

    Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and clinical attachment level measured with a manual periodontal probe (mm).

  6. Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI)

    Time frame: Baseline

    Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and plaque index assessed using the Silness-Löe Plaque Index (%).

  7. Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI)

    Time frame: Baseline

    Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and gingival index assessed using the Löe-Silness Gingival Index (score).

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer F. Okumuş, DDS,PhD

CONTACT

[email protected]

05532140969

Sponsors and collaborators

Lead sponsor

Ömer Faruk Okumuş

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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