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

December 1, 2025 updated by: Ömer Faruk Okumuş
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Erzincan
      • Erzincan, Erzincan, Turkey (Türkiye), 24002
        • Recruiting
        • Erzincan Binali Yıldırım University Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Healthy Control Group
Periodontally healthy individuals with no clinical attachment loss, probing depth ≤3 mm, no radiographic bone loss, and low gingival and plaque index scores.
Other: 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.
Experimental: Mild Periodontitis Group
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.
Other: 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.
Procedure: 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.
Experimental: Severe Periodontitis Group
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.
Other: 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.
Procedure: 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.
Experimental: Severe Periodontitis with Smoking Group
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).
Other: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months
Salivary Glutathione Peroxidase (GPx) Concentration
Time Frame: Baseline
GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L).
Baseline
Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration
Time Frame: Baseline
8-OHdG concentration measured in saliva using ELISA (ng/mL).
Baseline
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).
Baseline
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).
Baseline
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 (%).
Baseline
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ömer Faruk Okumuş

Investigators

  • Principal Investigator: Ömer F Okumuş, DDS,PhD, Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBYU-OKUMUS-MFN1-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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