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

NCT ID: NCT07262606

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-01

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Saliva Collection

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Non-surgical Periodontal Therapy (Scaling and Root Planing)

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Non-surgical Periodontal Therapy (Scaling and Root Planing)

Intervention Type: 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

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Non-surgical Periodontal Therapy (Scaling and Root Planing)

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ömer Faruk Okumuş

OTHER

Sponsor Role: lead

Responsible Party

Ömer Faruk Okumuş

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ömer F Okumuş, DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Erzincan Binali Yıldırım University Faculty of Dentistry

Erzincan, Erzincan, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ömer F. Okumuş, DDS,PhD

Role: CONTACT

okumus.omer24@gmail.com

05532140969

Facility Contacts

Ömer Faruk Okumuş

Role: primary

okumus.omer24@gmail.com

05532140969

Other Identifiers

EBYU-OKUMUS-MFN1-2025

Identifier Type: -

Identifier Source: org_study_id