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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical Periodontal Therapy (Scaling and Root Planing) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Mitofusin-1 (Mfn1) Concentration at Baseline | Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months |
| Salivary Glutathione Peroxidase (GPx) Concentration |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ömer F. Okumuş, DDS,PhD | Contact | 05532140969 | okumus.omer24@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ömer F Okumuş, DDS,PhD | Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erzincan Binali Yıldırım University Faculty of Dentistry | Recruiting | Erzincan | Erzincan | 24002 | Turkey (Türkiye) |
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|
| Saliva Collection | Other | 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. |
|
GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L). |
| Baseline |
| Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration | 8-OHdG concentration measured in saliva using ELISA (ng/mL). | 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). | 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). | 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 (%). | 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). | Baseline |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D055113 | Chronic Periodontitis |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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