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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Turkey
Erzincan Binali Yıldırım University Faculty of Dentistry
RECRUITING
Erzincan
Contact Information
Primary
Ömer F. Okumuş, DDS,PhD
okumus.omer24@gmail.com
05532140969
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 104
Treatments
Sham_comparator: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: Ömer Faruk Okumuş

This content was sourced from clinicaltrials.gov