Chronic Periodontitis (Disorder), Periodontal Disease
Conditions
Keywords
Mitofusin-1, Saliva, Biomarker, Periodontal Treatment, Smoking
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.
Interventions
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.
OTHERSaliva 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.
Sponsors
Ömer Faruk Okumuş
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Mitofusin-1 (Mfn1) Concentration at Baseline | Baseline | Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Glutathione Peroxidase (GPx) Concentration | Baseline | GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L). |
| Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration | Baseline | 8-OHdG concentration measured in saliva using ELISA (ng/mL). |
| Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD) | Baseline | Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and probing depth measured with a manual periodontal probe (mm). |
| Change in Salivary Mfn1 Concentration After Periodontal Therapy | Baseline and 3 months | Difference in salivary Mfn1 concentration (ng/mL) measured using ELISA at baseline and 3 months after non-surgical periodontal therapy in the periodontitis groups. |
| Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI) | Baseline | Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and plaque index assessed using the Silness-Löe Plaque Index (%). |
| Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI) | Baseline | 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). |
| Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL) | Baseline | 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). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactÖmer F. Okumuş, DDS,PhD
Outcome results
None listed