Periodontal DiseaseNCT07262606

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

A study testing Non-surgical Periodontal Therapy (Scaling and Root Planing) and Saliva Collection in people with Periodontal Disease and Chronic Periodontitis (Disorder), run by Ömer Faruk Okumuş at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Periodontal Disease, Chronic Periodontitis (Disorder)
What is being tested?: Non-surgical Periodontal Therapy (Scaling and Root Planing) and Saliva Collection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2025to 1 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erzincan Binali Yıldırım University Faculty of Dentistry
Erzincan, Erzincan, 24002

Other trials in Turkey (Türkiye)

About this study

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)
Being tested: Non-surgical Periodontal Therapy (Scaling and Root Planing), Saliva Collection
Keywords: Mitofusin-1, Saliva, Biomarker, Periodontal Treatment, Smoking
Medical subject headings: Periodontal Diseases, Chronic Periodontitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-surgical Periodontal Therapy (Scaling and Root Planing)Procedure or surgery
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 CollectionOther
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.

Study groups in NCT07262606
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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). Receives: Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing); Other: Saliva Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Salivary Mitofusin-1 (Mfn1) Concentration at Baseline
Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group.
Measured: Baseline

Secondary outcomes (7)

Change in Salivary Mfn1 Concentration After Periodontal Therapy
Difference in salivary Mfn1 concentration (ng/mL) measured using ELISA at baseline and 3 months after non-surgical periodontal therapy in the periodontitis groups.
Measured: Baseline and 3 months
Salivary Glutathione Peroxidase (GPx) Concentration
GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L).
Measured: Baseline
Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration
8-OHdG concentration measured in saliva using ELISA (ng/mL).
Measured: Baseline
Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and probing depth measured with a manual periodontal probe (mm).
Measured: Baseline
Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL)
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).
Measured: Baseline
Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and plaque index assessed using the Silness-Löe Plaque Index (%).
Measured: Baseline
Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI)
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).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20251 Jul 2026

First posted3 Dec 2025
Study start1 Nov 2025
Primary completion15 Apr 2026
Study completion1 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07262606
Sponsor's protocol ID: EBYU-OKUMUS-MFN1-2025
Status last verified: Oct 2026
First submitted: 21 Nov 2025
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response
ClinicalTrials.gov ID: NCT07262606
Acronym / sponsor ID: EBYU-OKUMUS-MFN1-2025
Conditions: Periodontal Disease, Chronic Periodontitis (Disorder)
Keywords: Mitofusin-1, Saliva, Biomarker, Periodontal Treatment, Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Ömer Faruk OkumuşUniversity, hospital or other
Study start: 1 Nov 2025 (actual)
Primary completion: 15 Apr 2026 (actual)
Study completion: 1 Jul 2026 (actual)
First posted: 3 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy Control Group	Sham comparator	Other: Saliva CollectionPeriodontally healthy individuals with no clinical attachment loss, probing depth ≤3 mm, no radiographic bone loss, and low gingival and plaque index scores.
Mild Periodontitis Group	Experimental	Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing), Other: Saliva CollectionNon-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.
Severe Periodontitis Group	Experimental	Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing), Other: Saliva CollectionNon-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.
Severe Periodontitis with Smoking Group	Experimental	Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing), Other: Saliva CollectionIndividuals 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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.
No clinical attachment loss. Probing depth ≤ 3 mm. No radiographic evidence of bone loss. Low gingival and plaque index scores.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Mild Periodontitis Group, Severe Periodontitis Group, Severe Periodontitis with Smoking Group
Saliva CollectionCollection 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.	Other	Healthy Control Group, Mild Periodontitis Group, Severe Periodontitis Group, Severe Periodontitis with Smoking Group

Primary outcome

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.

7 secondary outcomes

Change in Salivary Mfn1 Concentration After Periodontal Therapy
Time frame: Baseline and 3 months
Salivary Glutathione Peroxidase (GPx) Concentration
Time frame: Baseline
Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL)
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI)
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI)
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.

Related trials for Periodontal Disease

Not yet recruitingObservational study
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Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
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Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
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Recruiting
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Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ömer F Okumuş, DDS,PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary Mitofusin-1 (Mfn1) Concentration at Baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.