NCT07262606 Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response
| NCT ID | NCT07262606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ömer Faruk Okumuş |
| Condition | Periodontal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2025-11-01 with a primary completion date of 2026-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Ömer F Okumuş, DDS,PhD
PRINCIPAL INVESTIGATOR
Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology
Frequently Asked Questions
Who can join the NCT07262606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Periodontal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07262606 currently recruiting?
Yes, NCT07262606 is actively recruiting participants. Contact the research team at okumus.omer24@gmail.com for enrollment information.
Where is the NCT07262606 trial being conducted?
This trial is being conducted at Erzincan, Turkey (Türkiye).
Who is sponsoring the NCT07262606 clinical trial?
NCT07262606 is sponsored by Ömer Faruk Okumuş. The principal investigator is Ömer F Okumuş, DDS,PhD at Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology. The trial plans to enroll 104 participants.