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Recruiting NCT07262606

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

No phase Interventional Periodontal Disease Chronic Periodontitis (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-surgical Periodontal Therapy (Scaling and Root Planing), Saliva Collection.
Who it may be relevant to
Registry conditions: Periodontal Disease, Chronic Periodontitis (Disorder). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Salivary Mitofusin-1 (Mfn1) Concentration at Baseline [Time frame: Baseline]
Secondary outcome measures (7)
  • 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]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 1 center
  • Erzincan Binali Yıldırım University Faculty of Dentistry — Erzincan

Identifiers

NCT: NCT07262606 · EBYU-OKUMUS-MFN1-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗