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

NCT07262606 | Recruiting

• 1 other identifier: EBYU-OKUMUS-MFN1-2025
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Disease; Chronic Periodontitis (Disorder)

Keywords

Mitofusin-1; Saliva; Biomarker; Periodontal Treatment; Smoking

Outcome Measures

Primary Outcomes (1)

• Salivary Mitofusin-1 (Mfn1) Concentration at Baseline

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

  Baseline

Secondary Outcomes (7)

• Change in Salivary Mfn1 Concentration After Periodontal Therapy

  Baseline and 3 months

• Salivary Glutathione Peroxidase (GPx) Concentration

  Baseline

• Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration

  Baseline

• Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)

  Baseline

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

  Baseline

Study Arms (4)

Healthy Control Group

SHAM COMPARATOR

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

Mild Periodontitis Group

EXPERIMENTAL

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.

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

Severe Periodontitis Group

EXPERIMENTAL

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.

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

Severe Periodontitis with Smoking Group

EXPERIMENTAL

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).

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

Interventions

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.

Healthy Control Group; Mild Periodontitis Group; Severe Periodontitis Group; Severe Periodontitis with Smoking Group

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.

Mild Periodontitis Group; Severe Periodontitis Group; Severe Periodontitis with Smoking Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ömer Faruk Okumuş: lead

Study Sites (1)

Erzincan Binali Yıldırım University Faculty of Dentistry

Erzincan, Erzincan, 24002, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis; Smoking

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Ömer F Okumuş, DDS,PhD

  Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer F. Okumuş, DDS,PhD

CONTACT

05532140969; okumus.omer24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: November 1, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

TU (1)